NCT02734589

Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis

Terminated NA Last updated 1 June 2022

What this trial tests

NA trial testing Fecal transplantation in Ulcerative Colitis in 54 participants. Terminated before completion.

Timeline

24 January 2017

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Wolfson Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	54
Start date	24 January 2017
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	5 locations across France, Israel, Italy

Drugs / interventions tested

• Fecal transplantation — full drug profile →
• Unique novel Diet for UC and Unique novel Diet for the donor + FMT
• Unique novel Diet for UC

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Wolfson Medical Center

Who can join

Adults 18 to 70, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
   Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z
2. Fecal transplantation for treatment of inflammatory bowel disease.
   Imdad A, Nicholson MR, Tanner-Smith EE, Zackular JP, et al · · 2018 · cited 120× · PMID 30480772 · DOI 10.1002/14651858.cd012774.pub2
3. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
4. Gaps in knowledge and future directions for the use of faecal microbiota transplant in the treatment of inflammatory bowel disease.
   Yalchin M, Segal JP, Mullish BH, Quraishi MN, et al · · 2019 · cited 11× · PMID 31803254 · DOI 10.1177/1756284819891038