Status:
ACTIVE_NOT_RECRUITING
Prevention of Inflammatory Bowel Diseases in Persons at Risk The PIONIR (Preventing IBD Onset in Individuals at Risk) Trial
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
The Hospital for Sick Children
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
6-38 years
Phase:
NA
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 ri...
Detailed Description
Several important factors associated with CD onset have already been identified in the GEM analyses, such as elevated faecal calprotectin(FC),altered gut permeability, proteomics, anti-microbial serol...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05211518
Start Date
May 4 2021
End Date
December 1 2025
Last Update
August 21 2025
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel