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Synbiotics and Post-op Crohn's Disease

NCT04804046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-01-19

No results posted yet for this study

Summary

Crohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all thought to play a major role. Many patients with CD will require surgery to remove affected portions of the gut, with ileocecal resections being the most common procedure performed. Regrettably, there is up to an 85% chance that disease returns to the surgical site. Strong immune suppressive medications may help to prevent disease relapse. However, patients are then at risk of serious side effects. Currently, no ideal post-op care exists for CD patients.

This study aims to assess whether a post-op synbiotic therapy (i.e. probiotics plus dietary fiber) prevents disease relapse in participants with CD. To test this, participants will consume probiotics (strains of bifidobacteria) before their surgery and then probiotics plus fiber supplements after surgery. Probiotics are live bacteria that have been shown to reduce inflammation of the gut. Fiber is given after surgery to help promote beneficial bacterial taxa and prevent less favorable bacterial taxa from triggering CD relapse. Patients will take the supplements for 6 months following surgery. They will be seen monthly to assess the effects of treatment on quality of life, symptoms of disease recurrence, inflammatory markers, and the gut microbiome. All patients will also undergo a colonoscopy at the end of the study to check for endoscopic reoccurrence.

Conditions

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with three Bifidobacterium spp. (3x10\^9 CFU) plus three dietary fibers (24 g fiber) daily for six months.

OTHER

Digestible Maltodextrin

Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with Maltodextrin daily for six months.

Sponsors & Collaborators

  • W. Garfield Weston Foundation

    collaborator UNKNOWN

  • University of Alberta

    lead OTHER

Principal Investigators

  • Karen L Madsen, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804046 on ClinicalTrials.gov