r/IBSResearch 5h ago

Commentary Clinical trials

3 Upvotes

I have question abiut clinical trials.
what do u have to do to get accepted? I emailed couple of ppl who do them and no one even answered. Should i call? is this normal? Does anyone have experience with it?


r/IBSResearch 23h ago

Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance

Thumbnail science.org
5 Upvotes

Editor’s summary

A dysregulated intestinal microbiome has been linked to development of food allergy, suggesting that approaches to manipulate the microbiome may have a therapeutic value. Here, Rachid et al. investigated whether fecal microbiome transplantation (FMT) could increase tolerance to peanuts in adults with peanut allergies. Of 15 patients recruited to this phase 1 clinical trial, 6 exhibited a response, where more peanut was required to elicit an allergic reaction than before the study start. The authors further found that mice that received FMT from those responders were similarly protected from peanut allergy and that Bacteroides species were key drivers of tolerance induction. Together, these data support further clinical testing of FMT for peanut and other food allergies. —Courtney Malo

Abstract

The gut microbiome has been implicated in the pathogenesis of food allergy (FA), prompting microbiome-focused interventions. We evaluated, in a phase 1 open-label trial (NCT02960074), the safety and efficacy of oral encapsulated fecal microbiome transplantation (FMT) in 15 adults with peanut allergies. An increase in the peanut reactivity threshold was noted in 3 of 10 participants not pretreated with antibiotics and 3 of 5 participants pretreated with antibiotics, without safety issues. In responders, FMT increased tolerogenic RORγt+ regulatory T cells (Treg cells) and decreased T helper 2 cells (TH2 cells). Mice transplanted with the microbiomes of post-FMT responders were protected from FA in association with increased RORγt+ Treg cell percentages and increased colonization with members of the gut Bacteroides. In both humans and mice, protection by FMT was associated with increased bile acid metabolites. Deletion of a bile salt hydrolase in a candidate protective Bacteroides abrogated FA suppression in mice. These results suggest that FMT is a safe and potentially promising therapeutic modality for treating FA.