Randomized Control Trial for FMT

Published in the July 2015 of the Journal of Gastroenterology. Thought I would share.

Authors Results:

"Seventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%−33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared with 6 of 34 of those with UC >1 year (P = .04, Fisher’s exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo."

Authors Conclusion:

"FMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes."

31 yo male
Pancolitis Dx Oct 2014
Mostly in remission

Meds:
Lialda
Wellbutrin
Fish oil
VSL #3
Melatonin
Curcumin
Canasa PRN

What was most interesting to me is they used only 2 donors (donor A and donor B). Donor B was associated with the best chance of remission (7/9). Hopefully soon they can identify they people with the "best" microbiotic environment and perform a follow up trial. If that works maybe someday it will become standard of care. We can only hope. Either way 25% vs. 5% in only 7 weeks is as good as some of the immunosuppressant drugs approve for use.

The initial report was no significant effect. In July the published again after following some of the patients longer. At that point the result was significant,

But it required multiple weekly administrations, the donor seemed to make a difference, and the % getting remission is less than half than get remission on usual meds.

Other studies have also indicated that some sort of booster is every 6mo or yearly. The main import of the paper is that in controlled trials, the results are much much less impressive than the uncontrolled trials and case reports.

While significant, these results are more promise than achievement. Hopefully the learn more about the donor/patient microbiome match, or progress in isolating the effective microbes.

There were several threads here back in July when this came out, and a long thread when the initial results were published early in the year.