The good news is growing evidence of safety, and that no only is composition of gut microbes shifted, but the expression of CD4 and TH1 cells in the immune system also changes in favorable ways.
The disappointing news is that the percentage of those who were helped was only 35% which is less than mesalamine, and the percentage who got remission was only 20%, which is similar to placebo in other studies. SO it is safe, and is making changes thought to be helpful, but not a lot of evidence for efficacy.
But the study had only 20 people, and only one FMT. I think a series of FMT might show better results. They also used a mix form 2 donors to increase diversity of microbes.
I don't think poop is the future; but I have always had a hunch that the solution was going to be probiotic (or other manipulation of gut microbes).
Background: Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment to induce remission in ulcerative colitis.
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. Four patients (20%) 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.