NCT04082559: Bio-MDT

Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease

Status unknown NA Last updated 8 October 2020

What this trial tests

NA trial testing Arm 1- Antibiotics treatment in Inflammatory Bowel Diseases in 170 participants. Status unknown.

Timeline

11 June 2019

Primary endpoint
11 June 2021

11 June 2023

Quick facts

Lead sponsor	Rabin Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	170
Start date	11 June 2019
Primary completion	11 June 2021
Estimated completion	11 June 2023
Sites	1 location across Israel

Drugs / interventions tested

• Arm 1- Antibiotics treatment
• Arm 2- Antibiotics treatment
• Arm 1- Combination therapy (Antibiotics + diet)
• Arm 2- Combination therapy (Antibiotics + diet)
• Arm 1- Nutritional prevention
• Arm 2- Nutritional prevention
• Arm 3- Nutritional prevention

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Rabin Medical Center

Who can join

Adults 18 to 75, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis").

Based on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch.

Aims:

1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.
2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.
3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.
4. Identify predictors for response to specific antibiotic and dietary interventions.

Publications & conference data

3 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. Increasing adherence to the Mediterranean diet and lifestyle is associated with reduced fecal calprotectin and intra-individual changes in microbial composition of healthy subjects.
   Godny L, Reshef L, Sharar Fischler T, Elial-Fatal S, et al · · 2022 · cited 20× · PMID 36226673 · DOI 10.1080/19490976.2022.2120749
3. The Role of the Gut Microbiome in Inflammatory Bowel Disease: The Middle East Perspective
   El-Sayed A, Kapila D, Taha R, El-Sayed S, et al · · 2024