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

Summary

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

OTHER

Arm 1- Antibiotics treatment

Patients with active disease will be randomized and will receive a prescription antibiotic regimens

OTHER

Arm 2- Antibiotics treatment

Patients with active disease will be randomized and will receive a prescription antibiotic regimens

OTHER

Arm 1- Combination therapy (Antibiotics + diet)

Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).

OTHER

Arm 2- Combination therapy (Antibiotics + diet)

Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).

OTHER

Arm 1- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

OTHER

Arm 2- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

OTHER

Arm 3- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• Tel Aviv University

  collaborator OTHER

• Rabin Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-11

Primary Completion

2021-06-11

Completion

2023-06-11

Countries

• Israel

Study Locations