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Prebiotic

Prebiotics + Specialized Diet for Crohn's Disease Risk

N/A

Waitlist Available

Led By Levinus Dieleman, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 15 - 50;

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 3 and 6

Awards & highlights

Study Summary

This trial is testing whether a combination of a specific dietary fiber and a diet high in omega-3 fatty acids and low in omega-6 fatty acids can reduce leaky gut in people with a family history of Crohn's disease.

Who is the study for?

This trial is for healthy first-degree relatives of Crohn's disease patients, aged 15-50. Participants must not be pregnant or lactating, should agree to use birth control if applicable, and avoid dietary supplements and certain medications before and during the study. They cannot have gastrointestinal dysfunction, IBS, blood disorders, uncontrolled health conditions like diabetes or severe chronic diseases.Check my eligibility

What is being tested?

The study tests whether a combination of prebiotics (β-fructans) and a diet low in n-6 PUFAs/high in n-3 PUFAs can reduce 'leaky gut' in participants at risk for Crohn's disease. There are two groups: one receives prebiotics with the special diet; the other gets a placebo plus standard Canadian dietary guidelines.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort such as bloating or gas due to changes in diet and introduction of prebiotics. Since this is focused on dietary interventions rather than medication, severe side effects are less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 15 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 3 and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 3 and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 3 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in small intestinal permeability over 6 weeks

Secondary outcome measures

Changes in fecal microbiota and their metabolic activity

Changes in serum/plasma markers for intestinal permeability

Participant compliance and tolerability

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prebiotics + "Low n-6 PUFA Diet"Experimental Treatment2 Interventions

A combination of beta-fructans (12g/day) and a diet with reduced intake of n-6 PUFAs and higher intake of n-3 PUFAs.

Group II: Placebo + "Control Diet".Experimental Treatment2 Interventions

A combination of maltodextrin (5g/day) and a control diet following the guidelines of Canada's Food Guide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prebiotics

2008

N/A

~180

Maltodextrin

2016

Completed Phase 3

~1260

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,745 Total Patients Enrolled

Levinus Dieleman, MD, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

β-fructans (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03950336 — N/A

Healthy First Degree Relatives Research Study Groups: Placebo + "Control Diet"., Prebiotics + "Low n-6 PUFA Diet"

Healthy First Degree Relatives Clinical Trial 2023: β-fructans Highlights & Side Effects. Trial Name: NCT03950336 — N/A

β-fructans (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950336 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age qualification for this medical study limited to individuals over 50 years old?

"This medical study is seeking participants between the ages of 15 and 50."

Answered by AI

Are there presently opportunities to join this medical experimentation?

"The clinicaltrial.gov page for this medical study confirms that recruitment is open and ongoing since its initial posting on February 4th 2020, with the latest update being posted April 6th 2022."

Answered by AI

How many participants has this trial recruited thus far?

"Indeed, as per the information on clinicaltrials.gov, this trial is presently enrolling participants. It was initially advertised on February 4th 2020 and has been refreshed recently on April 6th 2022. There are 40 openings at a single medical centre."

Answered by AI

Is there any possibility that I might be accepted into this clinical trial?

"The requirements for participation in this clinical trial include being between 15 and 50 years of age with a diagnosis of ileocolitis. In total, 40 people can join the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients

2020. "Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03950336.

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