Investigating the effects of a blueberry-rich diet on colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age \> 18 years
* diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) for at least 6 months with mild to moderate chronic colitis (CD: Harvey-Bradshaw-Index Score 5-16; UC: Partial Mayo Score 2-6 and a Mayo endoscopy subscore of 1-2) or in clinical remission (CD: Harvey-Bradshaw-Index Score 0-4; UC: Partial Mayo Score 0-1 and a Mayo endoscopy subscore of 0)
* stable IBD-specific medication dosage for at least 3 months \[such as thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\]
* 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) or a sigmoidoscopy with CLE, if a colonoscopy has already been performed within the last 6 months and previous findings are available.
* signed informed consent form

Exclusion Criteria:

* IBD without previously diagnosed inflammation of the colon (e.g. Crohn's Disease without colitis)
* active flare of IBD with 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. clinically relevant fructose malabsorption)
* presence of known serious infectious diseases e.g. of the liver such as HIV, hepatitis B and C infection

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CEDUR — German inflammatory bowel disease registry

  This registry collects real-world health and treatment information from adults with Crohn's disease, ulcerative colitis, or indeterminate colitis in Germany to see how care, effectiveness, safety, and costs play out in routine practice.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.