Fermented plant-based diet for gut health and colitis

Fermented Vegan Optimized Diet in Health and Colitis

This project will test whether a fermented, plant-based (vegan) diet improves gut barrier function and symptoms in people with ulcerative colitis or Crohn's disease and in healthy volunteers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Region Skane (other)
• Locations: 2 sites (Malmö and 1 other locations)
• Trial ID: NCT06696222 on ClinicalTrials.gov

What this trial studies

This interventional trial compares a fermented, plant-based diet (including vegetarian yogurt and meat alternatives) with an ordinary meat-containing diet and placebo products in both healthy volunteers and people with IBD (ulcerative colitis or Crohn's disease). Participants follow the assigned diet for a set period while investigators collect stool, blood, and clinical data to measure mucus barrier integrity, microbiota composition, and short-chain fatty acid production. Key exclusions include antibiotic use in the past month and, for IBD participants, previous extensive bowel surgery. The trial aims to see if replacing processed animal products with fermented plant-based alternatives increases mucus production, reduces bacterial translocation, and improves symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults with ulcerative colitis or Crohn's disease who have not had extensive bowel surgery, as well as healthy adults without chronic illnesses or regular medications, and all participants must not have used antibiotics in the past month.

Not a fit: People who recently took antibiotics, have had extensive bowel surgery, have other chronic diseases requiring medication, or have severe unstable IBD are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the diet could strengthen the gut mucus barrier, boost beneficial microbiome metabolites like short-chain fatty acids, and reduce intestinal inflammation and symptoms for people with IBD.

How similar studies have performed: Smaller studies and observational data suggest high-fiber and fermented foods can modify the microbiome and sometimes improve symptoms, but large controlled trials in IBD are limited and results have been mixed.

Eligibility criteria

Inclusion Criteria:

* Healthy volunteers in two groups
* IBD in two groups (ulcerative colitis or Crohn's disease)

Exclusion Criteria:

* For healthy any disease requiring medication
* For IBD previous extensive operation
* For both antibiotics the past month

Where this trial is running

Malmö and 1 other locations

• Dept of Gastroenterology — Malmö, Sweden (RECRUITING)
• Dept of Gastroenterology — Malmö, Sweden (RECRUITING)

Study contacts

• Principal investigator: Klas Sjöberg, Adj prof — Dept of Gastroenterology
• Study coordinator: Klas Sjöberg, Adj prof

Conditions: Healthy Volunteers, Inflammatory Bowel Disease, diet, ulcerative colitis, Crohn&#39, s disease, vegetarian diet