Investigating the effects of a blueberry-rich diet on colitis
Impact of Wild Blueberries (Vaccinium Myrtillus) on the Intestinal Barrier, Microbiome and Inflammation in Chronic Colitis - a Prospective Randomized Crossover Study
This study is testing if eating a diet high in blueberries can help people with ulcerative colitis and Crohn's disease feel better by improving their gut health and reducing inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität Duisburg-Essen Academic / other |
| Drugs / interventions | infliximab, adalimumab, vedolizumab |
| Locations | 1 site (Bamberg, Bavaria) |
| Trial ID | NCT06698601 on ClinicalTrials.gov |
What this trial studies
This exploratory, prospective, monocentric randomized crossover study aims to evaluate how a diet rich in blueberries influences the microbiome, intestinal barrier, and inflammatory processes in patients with inflammatory bowel disease (IBD), specifically those with ulcerative colitis and Crohn's disease. Patients will be recruited during their inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg, Germany, where they will receive a comprehensive multimodal integrative therapy. The study will compare the effects of a blueberry-rich diet against a blueberry-poor diet on disease activity and symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a diagnosis of mild to moderate ulcerative colitis or Crohn's disease who are stable on their IBD-specific medications.
Not a fit: Patients with active IBD flare-ups or those who have a high regular consumption of blueberries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that may improve the management of inflammatory bowel disease.
How similar studies have performed: While dietary interventions in IBD have been explored, this specific approach focusing on wild blueberries is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) with mild to moderate colitis for at least 6 months (CD: Harvey-Bradshaw-Index Score 5-16; UC: Partial Mayo Score 2-6) * stable IBD-specific medication dosage for at least 3 months \[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\] * inpatient admission to the Department for Internal and Integrative Medicine at the Sozialstiftung Bamberg, Germany for regular treatment * clinical indication and performance of an initial colonoscopy with confocal laser endomicroscopy (CLE) * signed informed consent form Exclusion Criteria: * IBD without inflammation of the colon (e.g. Crohn's Disease without colitis) * active flare of IBD * CRP ≥ 100 mg/l * artificial bowel outlet in front of the colon (ileostomy) * high regular consumption of blueberries (≥ 300 g cultivated blueberries or ≥ 150 g wild blueberries per week) or administration of blueberry therapy in the last 3 months * participation in another therapeutic study within the last 30 days * Known intolerance to blueberries or their ingredients such as contained anthocyanins or fructose (e.g. fructose malabsorption) * presence of known serious infectious diseases e.g. of the liver such as HIV, hepatitis B and C infection
Where this trial is running
Bamberg, Bavaria
- Sozialstiftung Bamberg — Bamberg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Jost Langhorst, Univ. Prof. Dr. med. — Universität Duisburg-Essen
- Study coordinator: Angelika Schmalzl, Dr. rer. nat.
- Email: FIGN@sozialstiftung-bamberg.de
- Phone: 0049 951 503 11650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.