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

NCT05211518 | Completed

• 1 other identifier: PIONIR trial
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chron

Outcome Measures

Primary Outcomes (1)

• Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity.

  Fecal calprotectin (FC) is a validated, sensitive marker of intestinal inflammation and reflects short term biological changes expected from the Tasty \& Healthy intervention. For this reason, the primary endpoint is a reduction in FC over the 8 weeks of the intervention.

  8 weeks of Tasty&Healthy diet.

Secondary Outcomes (9)

• Change in the GEM integrative risk score

  8 weeks of Tasty & Healthy intervention

• Change in Microbiome risk score (MRS)

  8 weeks of Tasty&Healthy diet.

• Change in Lactulose-Mannitol Ratio (LMR).

  8 weeks of Tasty&Healthy diet.

• Change in Serum Metabolomics pre and post-intervention

  8 weeks of Tasty&Healthy diet.

• Change in Serum Proteomics pre and post-intervention

  8 weeks of Tasty&Healthy diet.

Study Arms (2)

Tasty&Healthy

OTHER

Tasty\&Healthy intervention: subjects will receive dietary advice to exclude pro-inflammatory dietary components

Other: Tasty&Healthy

Habitual diet

OTHER

Habitual diet: subjects will continue their habitual diet.

Other: Habitual diet

Interventions

Tasty&Healthy OTHER

exclude pro-inflammatory dietary components

Tasty&Healthy

Habitual diet OTHER

subjects will continue their habitual diet.

Habitual diet

Eligibility Criteria

• Age: 6 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)\>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD.
• Younger than 39 years of age, in order to maximize future risk of developing CD.
• No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are \>70μg/g.

You may not qualify if:

• Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis
• The use of antibiotics in the preceding month
• Prior intestinal resection
• Pregnancy (and up until six months after giving birth)
• Celiac disease or Diabetes
• Weight loss or weight gain by more than 20% body weight in the last 3 months
• Extraintestinal manifestations (Arthritis/arthralgia, iritis/uveitis, skin/mouth lesions, peri-anal disease, Other fistula).
• Underweight (children \<3th BMI percentile, adult above the age of 18 years: BMI\<18.5 kg/m2).

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: collaborator
• The Hospital for Sick Children: collaborator
• The Governors of the University of Alberta: collaborator
• University of Manitoba: collaborator
• IWK Health Centre: collaborator
• University of British Columbia: collaborator
• University of Calgary: collaborator
• McGill University: collaborator
• Beilinson Hospital, Petach Tikva,Israel: collaborator

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (4)

• Stulman MY, Asayag N, Focht G, Brufman I, Cahan A, Ledderman N, Matz E, Chowers Y, Eliakim R, Ben-Horin S, Odes S, Dotan I, Balicer RD, Benchimol EI, Turner D. Epidemiology of Inflammatory Bowel Diseases in Israel: A Nationwide Epi-Israeli IBD Research Nucleus Study. Inflamm Bowel Dis. 2021 Oct 20;27(11):1784-1794. doi: 10.1093/ibd/izaa341.

  PMID: 33438721 BACKGROUND

• Department of Error. Lancet. 2020 Oct 3;396(10256):e56. doi: 10.1016/S0140-6736(20)32028-6. No abstract available.

  PMID: 33010847 BACKGROUND

• Beard JA, Franco DL, Click BH. The Burden of Cost in Inflammatory Bowel Disease: A Medical Economic Perspective and the Future of Value-Based Care. Curr Gastroenterol Rep. 2020 Jan 30;22(2):6. doi: 10.1007/s11894-020-0744-z.

  PMID: 32002671 BACKGROUND

• Barnes C, Ashton JJ, Borca F, Cullen M, Walker DM, Beattie RM. Children and young people with inflammatory bowel disease attend less school than their healthy peers. Arch Dis Child. 2020 Jul;105(7):671-676. doi: 10.1136/archdischild-2019-317765. Epub 2020 Jan 14.

  PMID: 31937567 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dan Turner, Prof

  Saare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of The Juliet Keidan Institute of Pediatric Gastroenterology & Nutrition

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: January 27, 2022
• Study Start: May 4, 2021
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-08

Locations

IL (1)