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

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

OTHER

Fecal transplantation

Transplantation of fecal bacteria from a healthy individual into a recipient- ulcerative colitis patient via colonoscopy and enemas

OTHER

Unique novel Diet for UC and Unique novel Diet for the donor + FMT

A developed unique diet that is geared to induces remission and decreases inflammation in patients with active UC. Also a conditioning diet for healthy subjects to be used by the donor prior to transplantation- a developed unique diet for two weeks.

OTHER

Unique novel Diet for UC

A developed diet that is geared to induces remission and decreases inflammation in patients with active UC.

Sponsors & Collaborators

• Wolfson Medical Center

  lead OTHER_GOV

Principal Investigators

• Arie Levine, MD · Wolfson Medical Center

• Yona Avni, MD · Wolfson Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-24

Primary Completion

2020-12-30

Completion

2020-12-30

Countries

• France
• Israel
• Italy

Study Locations