Crohn'sUCRecruiting
Wild Blueberries in Colitis
Not applicable · Testing blueberry-rich diet and Control diet · 1 site · Universität Duisburg-Essen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing blueberry-rich diet (a dietary supplement) and Control diet as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- The study has 2 groups.
- Start date: 2024-12-05.
- Main results expected around 2028-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Germany.
Groups in this study
- Intervention group (listed as: experimental group)
- Control group
Main thing being measured
- Improvement of the intestinal inflammation status evaluated via fecal calprotectin levels (week 0, 12, 24)
In the researchers’ words
The goal of this exploratory, prospective, monocentric randomized crossover study is to investigate the influence of a blueberry-rich diet compared to a blueberry-poor diet on the microbiome, the intestinal barrier and the inflammatory process in IBD patients with chronic colitis. The main question the study aims to answer is: * Does a diet rich in blueberries compared to a diet low in blueberries have an influence…
Words you might see
- Randomized: participants are put into groups by chance, like a coin flip.
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Colonoscopy: a camera exam of the large intestine (colon).
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | Universität Duisburg-Essen |
| Collaborators | German Crohn's and Colitis Association (DCCV e.V.); Wilhelm Doerenkamp Foundation |
| Enrollment | 60 (estimated) |
| Start date | 2024-12-05 |
| Primary completion (est.) | 2028-01 |
| First posted | 2024-11-21 |
| Last updated | 2026-10-01 |
| Official title | Impact of Wild Blueberries (Vaccinium Myrtillus) on the Intestinal Barrier, Microbiome and Inflammation in Chronic Colitis - a Prospective Randomized Crossover Study |
| ClinicalTrials.gov ID | NCT06698601 |
Interventions
- blueberry-rich diet (Dietary Supplement)
The study participants follow a diet rich in blueberries for 12 weeks based on the nutritional therapy and the integrative medical concept taught during their inpatient stay at the clinic for internal and integrative medicine in Bamberg. Participants will drink approximately 35g of a powder made from wild, freeze-dried blueberries containing 780mg of anthocyanines stirred in a glas of water every… - Control diet (Other)
The study participants will focus on the nutritional therapy and the integrative medical concept taught during their inpatient stay at the clinic for internal and integrative medicine in Bamberg. Participants will receive no additional blueberry treatment.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sozialstiftung Bamberg | Bamberg, Bavaria | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.