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Advancing Care for Pediatric Patients with C. difficile: Insights from a Clinical Webinar on Investigational FMT

On March 28, 2023, OpenBiome convened a live webinar featuring a distinguished panel of physicians from Boston Children’s Hospital, Texas Children’s Hospital, and the University of Minnesota. The discussion focused on the clinical management of pediatric patients with Clostridioides difficile (C. difficile) infection, with a particular emphasis on diagnostic considerations and the use of investigational fecal microbiota transplantation (FMT). 

OpenBiome, winner of the 2023 GBCHealth Futurist Award

OpenBIome CEO, Julie Barrett O’Brien, accepting the GBC Health Futurist award at during UNGA. The award recognizes “future seeking, innovating, ‘ahead of the curve’ companies that stand to change the future of global health.”  “We are honored to accept this award,” said O’Brien, “and will use this platform to build a more equitable and inclusive system for microbiome scientists across the globe.”

How to Recruit and Engage Stool Donors

Stool banking depends on a pool of committed and healthy stool donors. Building a sustainable donor pool can be difficult as less than 3% of prospective donors may pass health screenings, necessitating a large recruitment effort. This paper reviews several considerations for recruiting stool donors including guidance on advertising, designing incentives, and maintaining clear communication with prospective and active donors.

Efficacy of Fecal Microbiota Transplantation for Clostridium difficile Infection in Children

Nicholson MR, Mitchell PD, Alexander E, Ballal S, Bartlett M, Becker P, Davidovics Z, Docktor M, Dole M, Felix G, Gisser J, Hourigan SK, Jensen MK, Kaplan JL, Kelsen J, Kennedy M, Khanna S, Knackstedt E, Leier M, Lewis J, Lodarek A, Michail S, Oliva-Hemker M, Patton T, Queliza K, Russell GH, Singh N, Solomon A, Suskind DL, Werlin S, Kellermayer R, Kahn SA. Efficacy of Fecal Microbiota Transplantation for Clostridium difficile Infection in Children. Clin Gastroenterol Hepatol. 2020 Mar;18(3):612-619.e1. doi: 10.1016/j.cgh.2019.04.037. Epub 2019 Apr 19. PMID: 31009795; PMCID: PMC7549313.

Outcomes of Fecal Microbiota Transplantation in Patients With Inflammatory Bowel Diseases and Recurrent Clostridioides difficile Infection

Allegretti, J., Kelly, C., Grinspan, A., Mullish, B., Kassam, Z., & Fischer, M. (2020). Outcomes of Fecal Microbiota Transplantation in Patients With Inflammatory Bowel Diseases and Recurrent Clostridioides difficile Infection. Gastroenterology, 159(5), 1982-1984. doi: 10.1053/j.gastro.2020.07.045

Fecal Microbiota Transplantation: An Introduction to FMT, its History, and Therapeutic Potential

Fecal Microbiota Transplantation (FMT) is a groundbreaking medical procedure that involves transplanting stool from a healthy donor into the gut of a recipient. This treatment helps restore the balance of bacteria in the intestine, offering powerful therapeutic benefits—most notably in the treatment of recurrent Clostridioides difficile (C. difficile) infections. 

Clinical Considerations for Donor Screening

Evaluating the health of stool donors providing Fecal Microbiota Transplantation (FMT) material is a crucial and dynamic aspect of stool banking. Donor selection criteria may vary depending on multiple factors such as geography and patient population, and is continually being updated to reflect the latest understanding of FMT and the microbiome. This paper reviews clinical considerations underlying donor selection using OpenBiome’s screening criteria as an example.

When is an FMT Treatment Ready for Use? Health Monitoring and Material Release

Stool banking is a complex, multi-step process that includes screening and monitoring donor health as well as manufacturing fecal microbiota transplantation (FMT) preparations from donated stool. To help ensure that FMT preparations meet the stool bank’s quality and safety standards, a Quality Department reviews all information associated with an FMT preparation and its donor to verify that it is suitable for patient treatment. This paper outlines and discusses basic quality checks that FMT material should pass before it is released for clinical use.

Tracking Patient Outcomes and Adverse Events: Considerations for Pharmacovigilance

Detection and response to reported safety events is one of a stool bank’s most important roles. A robust material tracking and pharmacovigilance program enables timely responses to suspected adverse events including safety measures to mitigate risk to patients receiving FMT at centers being supplied by the stool bank. This paper presents OpenBiome’s material tracking and pharmacovigilance program as an example for surveilling patient responses to FMT.

FMT Update & Future Directions

I am writing to share an important and transformative update about OpenBiome.

In light of the FDA’s recent decision to end enforcement discretion, we have had to make some difficult decisions—most notably, scaling back our exceptional team and ceasing the distribution of investigational Fecal Microbiota Transplants (FMT). The outcome, although unavoidable, deeply affects us all as we fully recognize the critical role this treatment has played for clinicians and the patients you care for, particularly those battling severe and fulminant Clostridioides difficile (C. diff) infections. Rest assured, however, that while it may take time, we are actively exploring new avenues to ensure patients can access this life-changing therapy.

Heterogeneity of Randomized Controlled Trials of Fecal Microbiota Transplantation in Recurrent Clostridioides difficile Infection

Feuerstadt P, Aroniadis OC, Svedlund FL, Garcia M, Stong L, Boules M, Khanna S. Heterogeneity of Randomized Controlled Trials of Fecal Microbiota Transplantation in Recurrent Clostridioides difficile Infection. Dig Dis Sci. 2021 Jul 18. doi: 10.1007/s10620-021-07141-9. Epub ahead of print. PMID: 34275058.

Cost-effectiveness analysis of sequential fecal microbiota transplantation for fulminant Clostridioides difficile infection

Gupta S, Zhu J, McCarty TR, Pruce J, Kassam Z, Kelly C, Fischer M, Allegretti JR. Cost-effectiveness analysis of sequential fecal microbiota transplantation for fulminant Clostridioides difficile infection. J Gastroenterol Hepatol. 2021 Sep;36(9):2432-2440. doi: 10.1111/jgh.15483. Epub 2021 Mar 17. PMID: 33682170.

ACG Clinical Guidelines

Kelly, C., Fischer, M., Allegretti, J., LaPlante, K., Stewart, D., & Limketkai, B. et al. (2021). ACG Clinical Guidelines. American Journal Of Gastroenterology, Publish Ahead of Print. doi: 10.14309/ajg.0000000000001278

Management of Severe and Severe/Complicated Clostridoides difficile Infection using Sequential Fecal Microbiota Transplant by Retention Enema

Rupawala AH, Gachette D, Bakhit M, Jimoh L, Kelly CR. Management of Severe and Severe/Complicated Clostridoides difficile Infection using Sequential Fecal Microbiota Transplant by Retention Enema. Clin Infect Dis. 2021 Jan 21:ciab041. doi: 10.1093/cid/ciab041. Epub ahead of print. PMID: 33476379.

Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile Infection

Song YN, Yang DY, Veldhuyzen van Zanten S, Wong K, McArthur E, Song CZ, Ianiro G, Cammarota G, Kelly C, Fischer M, Russell L, Kao D. Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile Infection: Systematic Review and Meta-analysis. J Can Assoc Gastroenterol. 2021 Jul 23;5(1):e1-e11. doi: 10.1093/jcag/gwab023. PMID: 35118227; PMCID: PMC8806043.

Systematic Review with Meta-Analysis: Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile

Tixier EN, Verheyen E, Luo Y, Grinspan LT, Du CH, Ungaro RC, Walsh S, Grinspan AM. Systematic Review with Meta-Analysis: Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile. Dig Dis Sci. 2021 Mar 22. doi: 10.1007/s10620-021-06908-4. Epub ahead of print. PMID: 33748913.

Understanding the mechanisms of efficacy of fecal microbiota transplant in treating recurrent Clostridioides difficile infection and beyond: the contribution of gut microbial-derived metabolites

Martinez-Gili, L., McDonald, J., Liu, Z., Kao, D., Allegretti, J., & Monaghan, T. et al. (2020). Understanding the mechanisms of efficacy of fecal microbiota transplant in treating recurrent Clostridioides difficile infection and beyond: the contribution of gut microbial-derived metabolites. Gut Microbes, 12(1), 1810531. doi: 10.1080/19490976.2020.1810531

Long-Term Efficacy and Safety of Fecal Microbiota Transplantation for Treatment of Recurrent Clostridioides difficile Infection

Perler, B., Chen, B., Phelps, E., Allegretti, J., Fischer, M., & Ganapini, V. et al. (2020). Long-Term Efficacy and Safety of Fecal Microbiota Transplantation for Treatment of Recurrent Clostridioides difficile Infection. Journal Of Clinical Gastroenterology, 1. doi:10.1097/mcg.0000000000001281

Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose

Allegretti, J., Fischer, M., Sagi, S., Bohm, M., Fadda, H., & Ranmal, S. et al. (2018). Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose. Digestive Diseases And Sciences, 64(6), 1672-1678. doi:10.1007/s10620-018-5396-6

Bezlotoxumab use as adjunctive therapy with the third fecal microbiota transplant in refractory recurrent Clostridium difficilecolitis; a case report and concise literature review

Kaako, A., Al-Amer, M., & Abdeen, Y. (2019). Bezlotoxumab use as adjunctive therapy with the third fecal microbiota transplant in refractory recurrent Clostridium difficile colitis; a case report and concise literature review. Anaerobe, 55, 112-116. doi:10.1016/j.anaerobe.2018.11.010

Frail Heart, Friable Colon: A Case Report of Fecal Microbiota Transplant for Refractory Clostridium difficile Infection in a Patient with Recent Trans-Catheter Aortic Valve Replacement

Bhanvadia, A. (2018) Frail Heart, Friable Colon: A Case Report of Fecal Microbiota Transplant for Refractory Clostridium difficile Infection in a Patient with Recent Trans-Catheter Aortic Valve Replacement. J Inflam Bowel Dis & Discord 3(1): 124.

Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience

Cheng, Y. W., Phelps E., Ganapini V., Khan N., Ouyang, F., Xu H., … & Fischer M. (2018) Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. American Journal of Transplantation, 10.1111/ajt.15058.

The association of donor stool consistency by Bristol stool scale on microbial profile and clinical outcomes of fecal microbiota transplantation in Clostridium difficile infection

Budree, S., Rao, S., Allegretti, J. R., Fischer, M., Kelly, C. R., Smith, M., … & Kassam, Z. (2017). The Association of Donor Stool Consistency by Bristol Stool Scale on Microbial Profile and Clinical Outcomes of Fecal Microbiota Transplantation in Clostridium Difficile Infection. Gastroenterology, 152(5), S630.

Fecal microbiota transplantation is safe and effective for the treatment of Clostridium difficile infection in solid organ transplant recipients

Piceno, Y. M., El-Nachef, N., Kassam, Z., Smith, M., Lynch, K., Zydek, M., … & Lynch, S. (2017). Fecal Microbiota Transplantation Differentially Influences the Gut Microbiota of Clostridium Difficile Infection and Ileal Pouch Anal Anastomosis Patients. Gastroenterology, 152(5), S1006.

Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety

Liu CK, Seo J, Pravodelov V, Frazier S, Guy M, Concilio K, Lau-Ng R, Brandeis G, Watson J, van der Velde J, Olesen SW, Budree S, Njenga M, Kassam Z, Osman M. Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety. Contemp Clin Trials Commun. 2022 Mar 7;27:100906. doi: 10.1016/j.conctc.2022.100906. PMID: 35299780; PMCID: PMC8921299

Stool processing speed and storage duration do not impact the clinical effectiveness of fecal microbiota transplantation

Jessica R. Allegretti, Ryan J. Elliott, Alim Ladha, Mary Njenga, Kurt Warren, Kelsey O’Brien, Shrish Budree, Majdi Osman, Monika Fischer, Colleen R. Kelly & Zain Kassam (2020): Stool processing speed and storage duration do not impact the clinical effectiveness of fecal microbiota transplantation. Gut Microbes, DOI: 10.1080/19490976.2020.1768777

Long-Term Outcomes Following Multiply Recurrent Clostridioides Difficile Infection and Fecal Microbiota Transplantation

Dawwas G, Brensinger CM, Vajravelu RK, Wu Q, Kelly CR, Laine L, Wu GD, Lewis JD. Long-Term Outcomes Following Multiply Recurrent Clostridioides Difficile Infection and Fecal Microbiota Transplantation. Clin Gastroenterol Hepatol. 2020 Dec 8:S1542-3565(20)31642-6. doi: 10.1016/j.cgh.2020.12.004. Epub ahead of print. PMID: 33307184

Risk of Clostridium difficile Infection with Systemic Antimicrobial Therapy Following Successful Fecal Microbiota Transplant: Should We Recommend Anti-Clostridium difficile Antibiotic Prophylaxis?

Allegretti, J., Kao, D., Phelps, E., Roach, B., Smith, J., & Ganapini, V. et al. (2019). Risk of Clostridium difficile Infection with Systemic Antimicrobial Therapy Following Successful Fecal Microbiota Transplant: Should We Recommend Anti-Clostridium difficile Antibiotic Prophylaxis?. Digestive Diseases And Sciences. doi:10.1007/s10620-018-5450-4

Risk Factors for Gastrointestinal Symptoms Following Successful Eradication of Clostridium difficile by Fecal Microbiota Transplantation (FMT)

Allegretti, J.R., Kassam, Z., Fischer, M., Kelly, C., & Chan W.W. (2019). Risk Factors for Gastrointestinal Symptoms Following Successful Eradication of Clostridium difficile by Fecal Microbiota Transplantation (FMT). Journal Of Clinical Gastroenterology, 1. doi:10.1097/mcg.0000000000001194

Outcomes of a Multidisciplinary Clinic in Evaluating Recurrent Clostridioides difficile Infection Patients for Fecal Microbiota Transplant: A Retrospective Cohort Analysis

Shin, J., Chaplin, A., Hays, R., Kolling, G., Vance, S., & Guerrant, R. et al. (2019). Outcomes of a Multidisciplinary Clinic in Evaluating Recurrent Clostridioides difficile Infection Patients for Fecal Microbiota Transplant: A Retrospective Cohort Analysis. Journal Of Clinical Medicine, 8(7), 1036. doi:10.3390/jcm8071036

Changes in microbiota composition, bile and fatty acid metabolism, in successful faecal microbiota transplantation for Clostridioides difficile infection

Brown, J. R. M., Flemer, B., Joyce, S. A., Zulquernain, A., Sheehan, D., Shanahan, F., & O’Toole, P. W. (2018). Changes in microbiota composition, bile and fatty acid metabolism, in successful faecal microbiota transplantation for Clostridioides difficile infection. BMC Gastroenterology, 18(1), 131.

Do Clinical Factors Affect Microbial Engraftment After Fecal Microbiota Transplantation in Recurrent Clostridium difficile Infection?

Budree, S., Osman, M., Panchal, P., Shu, E., Carrellas, M., Kassam, Z., & Allegretti, J. (2018, November). 618. Do Clinical Factors Affect Microbial Engraftment After Fecal Microbiota Transplantation in Recurrent Clostridium difficile Infection?. Open Forum Infectious Diseases (Vol. 5, No. suppl_1, pp. S225-S226). US: Oxford University Press.

Scaling Access to Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection in the United States: A Geospatial Time-Series Analysis from 2013 to 2017

Panchal, P., Elliott, R. J., Budree, S., Osman, M., Allegretti, J. R., Kelly, C. R., … & Kassam, Z. (2018). 1010-Scaling Access to Fecal Microbiota Transplantation for Recurrent Clostridium Difficle Infection in the United States: A Geospatial Time-Series Analysis from 2013 to 2017. Gastroenterology, 154(6), S-190.

Scaling Pediatric Access to Fecal Microbiota Transplantation in the United States: A Time-Series Geospatial Analysis

Panchal, P., Kahn, S., Zellmer, C., Kassam, Z., Osman, M., Allegretti, J., … & NASPGHAN FMT Special Interest Group. (2018, November). 533. Scaling Pediatric Access to Fecal Microbiota Transplantation in the United States: A Time-Series Geospatial Analysis. Open Forum Infectious Diseases (Vol. 5, No. suppl_1, pp. S197-S197). US: Oxford University Press.

Classifying Fecal Microbiota Transplantation Failure: An Observational Study Examining Timing and Characteristics of Fecal Microbiota Transplantation Failures.

Allegretti, J. R., Phelps, E., Allegretti, A., Xu, H., Fischer, M., & Kassam, Z. (2017). Classifying Fecal Microbiota Transplantation Failure: An Observational Study Examining Timing and Characteristics of Fecal Microbiota Transplantation Failures. Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association.

Should we recommend anti-Clostridium difficile antibiotic or probiotic prophylaxis? Risk of Clostridium difficile infection with systemic antimicrobial therapy following successful fecal microbiota transplant

Fischer, M., Kao, D. H., Phelps, E. L., Smith, J. D., Roach, B., Kassam, Z., … & Allegretti, J. R. (2017). Should we Recommend Anti-Clostridium Difficile Antibiotic or Probiotic Prophylaxis?: Risk of Clostridium Difficile Infection with Systemic Antimicrobial Therapy Following Successful Fecal Microbiota Transplant. Gastroenterology, 152(5), S1005.

Fecal microbiota transplantation is safe and effective for the treatment of Clostridium difficile infection in solid organ transplant recipients

Fischer, M., Khan, M., Phelps, E. L., Safdar, N., Misch, E. A., Kaur, N., … & Xu, H. (2017). Fecal Microbiota Transplantation is Safe and Effective for the Treatment of Clostridium Difficile Infection in Solid Organ Transplant Recipients. Gastroenterology, 152(5), S1005.

Pediatric access to fecal microbiota transplantation for recurrent Clostridium difficile Infection in the United States and the impact of stool banks: a geospatial analysis

Panchal, P., Budree, S., Tu, E., Kahn, S. A., Allegretti, J. R., Fischer, M., … & Osman, M. (2017). Pediatric Access to Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection in the United States and the Impact of Stool Banks: A Geospatial Analysis. Gastroenterology, 152(5), S849-S850.

Safety and Efficacy of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection From An International Public Stool Bank: Results From a 2050-Patient Multicenter Cohort

Osman, M., O’Brien, K., Stoltzner, Z., Ling, K., Koelsch, E., & Dubois, N. et al. (2016). Safety and Efficacy of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection From An International Public Stool Bank: Results From a 2050-Patient Multicenter Cohort. Open Forum Infectious Diseases, 3(suppl_1). doi:10.1093/ofid/ofw172.1668

Prospective Assessment of Donor Eligibility for Fecal Microbiota Transplantation at a Public Stool Bank: Results From the Evaluation of 1,387 Candidate Donors

Dubois, N., Ling, K., Osman, M., Burns, L., Mendolia, G., Blackler, D., Burgess, J., Edelstein, C., Noh, A., Vo, E., Alm E., Smith, M., and Kassam, Z. (2015). Prospective Assessment of Donor Eligibility for Fecal Microbiota Transplantation at a Public Stool Bank: Results From the Evaluation of 1,387 Candidate Donors. Idsa. Retrieved from https://idsa.confex.com/idsa/2015/webprogram/Paper52979.html

Does the Donor Matter? Microbiome Sequencing to Evaluate Lower Donor Efficacy in Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection

Osman, M., Abend, A., Panchal, P., Kassam, Z., & Budree, S. (2018). 88-Does the Donor Matter? Microbiome Sequencing to Evaluate Lower Donor Efficacy in Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection. Gastroenterology, 154(6), S-25.

Donor stool processing time: the effect on the intestinal microbiome and clinical outcomes of fecal microbiota transplantation in Clostridium difficile Infection

Budree, S., Elliott, R. J., Rao, S., Njenga, M., Ladha, A., Allegretti, J. R., … & Kassam, Z. (2017). Donor Stool Processing Time: The Effect on the Intestinal Microbiome and Clinical Outcomes of Fecal Microbiota Transplantation in Clostridium Difficile Infection. Gastroenterology, 152(5), S1006.

The association of donor stool consistency by Bristol stool scale on microbial profile and clinical outcomes of fecal microbiota transplantation in Clostridium difficile infection

Budree, S., Rao, S., Allegretti, J. R., Fischer, M., Kelly, C. R., Smith, M., … & Kassam, Z. (2017). The Association of Donor Stool Consistency by Bristol Stool Scale on Microbial Profile and Clinical Outcomes of Fecal Microbiota Transplantation in Clostridium Difficile Infection. Gastroenterology, 152(5), S630.

The association of stool donor diet on microbial profile and clinical outcomes of fecal microbiota transplantation in clostridium difficile infection

Budree, S., Tu, E., Leith, T., Allegretti, J. R., Rao, S., Day, R., … & Osman, M. (2017). The Association of Stool Donor Diet on Microbial Profile and Clinical Outcomes of Fecal Microbiota Transplantation in Clostridium Difficile Infection. Gastroenterology, 152(5), S630-S631.

Do Specific Bacteria Drive Clinical Cure in Fecal Microbiota Transplantation for Clostridium Difficile Infection?: Clinical, Microbial and Metabolomic Characterization of Universal FMT Donors

Budree, S., Wong, W. F., Tu, E., Rao, S., Allegretti, J. R., Fischer, M., … & Kassam, Z. (2017). Do Specific Bacteria Drive Clinical Cure in Fecal Microbiota Transplantation for Clostridium Difficile Infection?: Clinical, Microbial and Metabolomic Characterization of Universal FMT Donors. Gastroenterology, 152(5), S349.

Stool Donor Body Mass Index Does Not Affect Recipient Weight After a Single Fecal Microbiota Transplantation for Clostridium difficile Infection

Fischer, M., Kao, D., Kassam, Z., Smith, J., Louie, T., Sipe, B., … & Allegretti, J. R. (2017). Stool Donor Body Mass Index Does Not Affect Recipient Weight After a Single Fecal Microbiota Transplantation for C. difficile Infection. Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association.

Dynamic Colonization of Microbes and Their Functions after Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Chu ND, Crothers JW, Nguyen LTT, Kearney SM, Smith MB, Kassam Z, Collins C, Xavier R, Moses PL, Alm EJ. Dynamic Colonization of Microbes and Their Functions after Fecal Microbiota Transplantation for Inflammatory Bowel Disease. mBio. 2021 Aug 31;12(4):e0097521. doi: 10.1128/mBio.00975-21. Epub 2021 Jul 20. PMID: 34281401; PMCID: PMC8406238.

Fecal Microbiota Transplantation for the Treatment of Ulcerative Colitis: A Qualitative Assessment of Patient Perceptions and Experiences

Chauhan U, Popov J, Farbod Y, Kalantar M, Wolfe M, Moayyedi P, Marshall JK, Halder S, Kaasalainen S. Fecal Microbiota Transplantation for the Treatment of Ulcerative Colitis: A Qualitative Assessment of Patient Perceptions and Experiences. J Can Assoc Gastroenterol. 2021 Mar 26;4(6):e120-e129. doi: 10.1093/jcag/gwab007. PMID: 34877470; PMCID: PMC8643654.

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study

Crothers JW, Chu ND, Nguyen LTT, Phillips M, Collins C, Fortner K, Del Rio-Guerra R, Lavoie B, Callas P, Velez M, Cohn A, Elliott RJ, Wong WF, Vo E, Wilcox R, Smith M, Kassam Z, Budd R, Alm EJ, Mawe GM, Moses PL. Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. BMC Gastroenterol. 2021 Jul 8;21(1):281. doi: 10.1186/s12876-021-01856-9. PMID: 34238227; PMCID: PMC8268596.

Transferable IgA-coated Odoribacter splanchnicus in Responders to Fecal Microbiota Transplantation for Ulcerative Colitis Limits Colonic Inflammation

Lima S, Gogokhia L, Viladomiu M, Chou L, Putzel G, Jin W, Pires S, Guo CJ, Gerardin Y, Crawford CV, Jacob V, Scherl E, Brown SE, Hambor J, Longman R. Transferable IgA-coated Odoribacter splanchnicus in Responders to Fecal Microbiota Transplantation for Ulcerative Colitis Limits Colonic Inflammation. Gastroenterology. 2021 Oct 1:S0016-5085(21)03610-6. doi: 10.1053/j.gastro.2021.09.061. Epub ahead of print. PMID: 34606847.

Inflammatory Bowel Disease Outcomes Following Fecal Microbiota Transplantation for Recurrent C. difficile Infection

Allegretti JR, Kelly CR, Grinspan A, Mullish BH, Hurtado J, Carrellas M, Marcus J, Marchesi JR, McDonald JAK, Gerardin Y, Silverstein M, Pechlivanis A, Barker GF, Miguens Blanco J, Alexander JL, Gallagher KI, Pettee W, Phelps E, Nemes S, Sagi SV, Bohm M, Kassam Z, Fischer M. Inflammatory Bowel Disease Outcomes Following Fecal Microbiota Transplantation for Recurrent C. difficile Infection. Inflamm Bowel Dis. 2020 Nov 6:izaa283. doi: 10.1093/ibd/izaa283. Epub ahead of print. PMID: 33155639.

Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment

Herfarth, H., Barnes, E. L., Long, M. D., Isaacs, K. L., Leith, T., Silverstein, M., … Kassam, Z. (2019). Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment. Inflammatory Intestinal Diseases, 1–6. doi:10.1159/000497042

Does Rifaximin prior to fecal microbiota transplantation improve clinical outcomes compared to microbiome restoration alone in ulcerative colitis? A cohort study evaluating the impact of non-absorbable antibiotic pretreatment

El-Nachef, N., Kassam, Z., Piceno, Y. M., Ablaza, A. J., Zydek, M., Elliott, R. J., … & Somsouk, M. (2017). Does Rifaximin Prior to Fecal Microbiota Transplantation Improve Clinical Outcomes Compared to Microbiome Restoration Alone in Ulcerative Colitis? a Cohort Study Evaluating the Impact of Non-Absorbable Antibiotic Pretreatment. Gastroenterology, 152(5), S1008-S1009.

The role of fecal microbiota transplantation in ulcerative colitis and Crohn’s disease: results from a parallel inflammatory bowel disease cohort study

El-Nachef, N., Piceno, Y. M., Kassam, Z., Ablaza, A. J., Zydek, M., Lynch, K., … & Lynch, S. (2017). The Role of Fecal Microbiota Transplantation in Ulcerative Colitis and Crohn’s Disease: Results from a Parallel Inflammatory Bowel Disease Cohort Study. Gastroenterology, 152(5), S1008.

Can you cause inflammatory bowel disease with fecal transplantation? A 31-patient case-series of fecal transplantation using stool from a donor who later developed Crohn’s disease

Fischer, M., Bittar, M., Papa, E., Kassam, Z., & Smith, M. (2017). Can you cause inflammatory bowel disease with fecal transplantation? A 31-patient case-series of fecal transplantation using stool from a donor who later developed Crohn’s disease. Gut microbes, 8(3), 205-207.

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Jacob, V., Crawford, C., Cohen-Mekelburg, S., Viladomiu, M., Putzel, G. G., Schneider, Y., … & Ajami, N. J. (2017). Single delivery of high-diversity fecal microbiota preparation by colonoscopy is safe and effective in increasing microbial diversity in active ulcerative colitis. Inflammatory bowel diseases, 23(6), 903-911.

Fecal microbiota transplantation differentially influences the gut microbiota of Clostridium difficile infection and ileal pouch anal anastomosis patients

Piceno, Y. M., El-Nachef, N., Kassam, Z., Smith, M., Lynch, K., Zydek, M., … & Lynch, S. (2017). Fecal Microbiota Transplantation Differentially Influences the Gut Microbiota of Clostridium Difficile Infection and Ileal Pouch Anal Anastomosis Patients. Gastroenterology, 152(5), S1006.

Fecal Microbiota Transplantation is Safe and Efficacious for Recurrent or Refractory Clostridium difficile Infection in Patients with Inflammatory Bowel Disease

Fischer, M., Kao, D., Kelly, C., Kuchipudi, A., Jafri, S. M., Blumenkehl, M., … & Cook, G. (2016). Fecal microbiota transplantation is safe and efficacious for recurrent or refractory Clostridium difficile infection in patients with inflammatory bowel disease. Inflammatory bowel diseases, 22(10), 2402-2409.

Fecal Microbiota Transplant in Cirrhosis Reduces Gut Microbial Antibiotic Resistance Genes: Analysis of Two Trials

Bajaj JS, Shamsaddini A, Fagan A, Sterling RK, Gavis E, Khoruts A, Fuchs M, Lee H, Sikaroodi M, Gillevet PM. Fecal Microbiota Transplant in Cirrhosis Reduces Gut Microbial Antibiotic Resistance Genes: Analysis of Two Trials. Hepatol Commun. 2020 Nov 21;5(2):258-271. doi: 10.1002/hep4.1639. PMID: 33553973; PMCID: PMC7850310.