Current Collaborations

Driven by our mission to catalyze research into the human microbiome, we both develop our own clinical trials and support researchers with a suite of tools that include screened and characterized fecal microbiota, assistance with trial design, and regulatory support. Below you can find information about OpenBiome sponsored and OpenBiome supported research studies.

Highlights from the Pipeline

    • A multi-center, longitudinal study sponsored by OpenBiome that aims to prospectively investigate short- and long-term safety and efficacy of FMT in treating recurrent C. difficile; this study is currently enrolling participants. Click here to read more and find out how to get involved.

    • Research site: University of Vermont Medical Center
    • Research group: Moses
    • Disease Indication: Ulcerative Colitis
    • Study design: Double-blind, randomized controlled trial (n=20)
    • Status: Completed enrollment

    • This double-blind RCT is led by Dr. Peter Moses at The University of Vermont Medical Center. The study is investigating the impact of FMT to placebos for the treatment of ulcerative colitis in adults (n = 20, 10 per arm). The study will consist of pre-treatment with antibiotics, induction with FMP 250 via colonoscopy, and maintenance with FMP capsules. The primary outcomes are the IBDQ and the SF-36 and the secondary outcomes include 16S rRNA sequencing, fecal lactoferrin, fecal calprotectin, mucosal biopsies, and metabolomics with a follow-up duration of nine months. This clinical trial is being conducted by The University of Vermont Medical Center.

    • Research site: Montefiore Medical Center
    • Research group: Aroniadis
    • Disease Indication: Irritable Bowel Syndrome
    • Study design: Double-blinded, placebo-controlled randomized controlled trial (n=110)
    • Status: Enrolling

    • This double-blind, crossover RCT is led by Dr. Olga Aroniadis at Montefiore Medical Center. The study is investigating the impact of FMP capsules and placebo capsules on adult diarrhea-predominant irritable bowel syndrome in adults (n = 110, 55 per arm). The primary outcome is change in symptom severity, assessed by the IBS-SSS, and secondary outcomes include change in quality of life and 16S rRNA sequencing with a follow-up duration of 12 weeks. This clinical trial is being conducted at Montefiore, Medical Research Center of Connecticut/Yale-New Haven, and Concorde Medical Group, PLLC.

    • Research site: Beth Israel Deaconess Medical Center
    • Research group: Lembo
    • Disease Indication: Irritable Bowel Syndrome
    • Study design: Double-blinded, placebo-controlled randomized controlled trial
    • Status: Enrolling

    • This double-blind RCT is led by Dr. Anthony Lembo at Beth Israel Deaconess Medical Center. The study is investigating the impact of FMT and placebo capsules on diarrhea-predominant irritable bowel syndrome in adults. The primary outcome is stable engraftment of donor microbiota as defined with the Jensen-Shannon Divergence at 10 weeks.

    • Research site: Beth Israel Deaconess Medical Center
    • Research group: Moss
    • Disease Indication: Crohn's disease
    • Study design: Single-blinded, randomized controlled trial (n=44)
    • Status: Enrolling

    • This randomized, single-blind trial is led by Dr. Alan Moss at Beth Israel Deaconess Medical Center. The study is comparing FMT to no therapy in the prevention of endoscopic recurrence of Crohn's Disease in adults (n = 44). The treatment arm will include colonoscopic induction of FMT followed by FMP capsule maintenance. The primary outcome is the Rutgeerts score and secondary outcomes include clinical remission, safety, 16S rRNA sequencing, biopsies, CRP, and fecal calprotectin with a follow-up duration of six months. This clinical trial is being conducted at Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, and Boston Medical Center.

    • Research site: Boston Children's Hospital
    • Research group: Russell/Bousvaros
    • Disease indication: Pediatric Ulcerative Colitis
    • Study design: Double-blinded, placebo controlled (n=60)
    • Status: Pre-enrollment

    • This double-blind, placebo controlled study is led by Dr. George Russell and Dr. Athos Bousvaros at Boston Children's Hospital. The study is investigating the impact of FMT on active pediatric ulcerative colitis (n = 60, 30 per arm). The treatment arm will consist of pre-treatment with broad-spectrum antibiotics, induction with FMP 250 via enema, and maintenance with FMP capsules. The primary outcomes are adverse events of grades 2+, improvement in PUCAI of 20+, and PROs while secondary outcomes include remission PUCAI less than nine, fecal calprotectin/lactoferrin, blood testing (ESR, CRP, albumin, hematocrit), and 16S rRNA sequencing with a follow-up duration of eight weeks. Patients responding to the treatment arm or failing placebo will have the option of entering an open-label, six-month course of FMT after the trial is complete. This clinical trial is being conducted at Boston Children's Hospital.

How to Collaborate with Us

If you are interested in proposing a research collaboration, please email us at science@openbiome.org, along with the CVs of key study personnel.

Before submitting the email, we encourage you to review our reference documents to inform your proposal. After reviewing your proposal, our Scientific Advisory Board will review your request and reach out to discuss how we can best support you and your research goals.

Reference Documents