Prevention of Inflammatory Bowel Diseases in Persons at Risk The PIONIR (Preventing IBD Onset in Individuals at Risk) Trial

Summary

The goal of this study is to explore in a cross over randomized controlled trial, the ability of the Tasty\&Healthy dietary intervention (NCT04239248) to alter the parameters associated with future risk of developing Chron's disease (CD) using First Degree Relatives of patients with Crohn's disease, including subjects identified in the Genetic Environmental Microbiome (GEM) Study as having a high-risk score. Specifically, the investigators aim to determine if the Tasty\&Healthy dietary intervention can decrease the overall GEM Risk Score (GRS) and/or to alter the individual biological parameters that contribute to this score. The investigators hypothesize that the Tasty\&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GRS.

Conditions

• Inflammatory Bowel Diseases

Interventions

OTHER

Tasty&Healthy

exclude pro-inflammatory dietary components

OTHER

Habitual diet

subjects will continue their habitual diet.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• The Governors of the University of Alberta

  collaborator UNKNOWN

• University of Manitoba

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• McGill University

  collaborator OTHER

• Beilinson Hospital, Petach Tikva,Israel

  collaborator UNKNOWN

• Shaare Zedek Medical Center

  lead OTHER

Principal Investigators

• Dan Turner, Prof · Saare Zedek Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

38 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-04

Primary Completion

2026-01-15

Completion

2026-01-15

Countries

• Israel

Study Locations