Abstract | BACKGROUND: METHODS: We designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active ulcerative colitis using a 2-donor fecal microbiota preparation ( FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed. Fecal DNA and rectal biopsies were used to characterize the microbiome and mucosal CD4 T cells, respectively, before and after FMT. RESULTS: Of the 20 patients enrolled in this study, 7 patients (35%) achieved a clinical response by week 4. Three patients (15%) were in remission at week 4 and 2 of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care. No serious adverse events were observed. Microbiome analysis revealed that restricted diversity of recipients pre-FMT was significantly increased by high-diversity 2-donor FMP. The microbiome of recipients post-transplant was more similar to the donor FMP than the pretransplant recipient sample in both responders and nonresponders. Notably, donor composition correlated with clinical response. Mucosal CD4 T-cell analysis revealed a reduction in both Th1 and regulatory T-cells post-FMT. CONCLUSIONS: High-diversity, 2-donor FMP delivery by colonoscopy seems safe and effective in increasing fecal microbial diversity in patients with active ulcerative colitis. Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.
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Authors | Vinita Jacob, Carl Crawford, Shirley Cohen-Mekelburg, Monica Viladomiu, Gregory G Putzel, Yecheskel Schneider, Fatiha Chabouni, Sarah OʼNeil, Brian Bosworth, Viola Woo, Nadim J Ajami, Joseph F Petrosino, Ylaine Gerardin, Zain Kassam, Mark Smith, Iliyan D Iliev, Gregory F Sonnenberg, David Artis, Ellen Scherl, Randy S Longman |
Journal | Inflammatory bowel diseases
(Inflamm Bowel Dis)
Vol. 23
Issue 6
Pg. 903-911
(06 2017)
ISSN: 1536-4844 [Electronic] England |
PMID | 28445246
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Aged
- CD4-Positive T-Lymphocytes
(cytology)
- Colitis, Ulcerative
(microbiology, therapy)
- Colonoscopy
- Fecal Microbiota Transplantation
(methods)
- Feces
(microbiology)
- Female
- Gastrointestinal Microbiome
- Humans
- Male
- Middle Aged
- New York
- Pilot Projects
- Prospective Studies
- RNA, Ribosomal, 16S
(genetics)
- Rectum
(pathology)
- Remission Induction
- Treatment Outcome
- Young Adult
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