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Synbiotics for Crohn's Disease

N/A

Waitlist Available

Led By Karen L Madsen, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month period

Awards & highlights

Study Summary

This trial will assess whether a synbiotic therapy can prevent disease relapse in Crohn's Disease patients post-operatively.

Who is the study for?

This trial is for individuals with Crohn's disease who are about to have ileocolonic resection surgery. They must be able to use approved birth control if of childbearing potential and not be pregnant. Excluded are those with gluten or milk/soy allergies, psychological disorders, gut perforation/ischemia, severe diseases like AIDS or cancer, or on certain medications.Check my eligibility

What is being tested?

The study tests whether synbiotic therapy (probiotics plus dietary fiber) after surgery can prevent Crohn's disease relapse. Participants will take probiotics before and after surgery along with fiber supplements for six months while their health outcomes are monitored.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort due to the introduction of new bacteria from probiotics and possible changes in bowel habits from increased fiber intake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month period

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

Treatment Details

Study Objectives

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

Primary outcome measures

The percentage of participants who experience treatment emergent adverse and serious adverse events

Secondary outcome measures

Changes in fecal bile acids

Changes in fecal short chain fatty acids

Changes in intestinal barrier function

+9 more

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT02124759

14%

Vasovagal Syncope

14%

Nausea

14%

Abdominal Bloating/Flatulence

14%

Mouth Ulcers

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sevelamer

Synbiotic

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SynbioticExperimental Treatment1 Intervention

Bifidobacterium longum spp. longum R0175, Bifidobacterium animalis spp. Lafti B94, Bifidobacterium bifidum R0071 at 3x10^9 CFU/d plus resistant starch type 2, arabinoxylan, and galactooligosaccharide at 24 g/d will serve as the treatment.

Group II: Digestible MaltodextrinPlacebo Group1 Intervention

Digestible maltodextrin will serve as the placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Synbiotic

2016

Completed Phase 3

~1290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,954 Total Patients Enrolled

W. Garfield Weston FoundationUNKNOWN

2 Previous Clinical Trials

188 Total Patients Enrolled

Karen L Madsen, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

Synbiotic Clinical Trial Eligibility Overview. Trial Name: NCT04804046 — N/A

Crohn's Disease Research Study Groups: Digestible Maltodextrin, Synbiotic

Crohn's Disease Clinical Trial 2023: Synbiotic Highlights & Side Effects. Trial Name: NCT04804046 — N/A

Synbiotic 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804046 — N/A

Frequently Asked Questions

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

What is the maximum capacity for this trial?

"The listing on clinicaltrials.gov says that this trial is still open for recruitment. The first posting was on July 15th, 2021 and the most recent update was on January 10th, 2022. Up to 36 patients can be enrolled at 5 different sites."

Answered by AI

Do the requirements for this clinical trial include being over the age of 80?

"This particular clinical trial is only open to patients that fall between 18-75 years old. Out of the 467 total trials, 69 are specific for minors and 199 are senior citizen exclusive."

Answered by AI

Could I join this clinical trial as a test subject?

"This study is looking for 36 individuals that currently suffer from Crohn disease and are between the ages of 18-75. Furthermore, it is a requirement that these patients also meet the following: they must be undergoing ileocolonic resection."

Answered by AI

Can people with the condition still join this research project?

"The trial, which was established on July 15th 2021 according to information found on clinicaltrials.gov, is currently looking for study participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Synbiotics and Post-op Crohn's Disease

2021. "Synbiotics and Post-op Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04804046.