Actively Recruiting
Wild Blueberries in Colitis
Led by Universität Duisburg-Essen · Updated on 2024-11-27
60
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
U
Universität Duisburg-Essen
Lead Sponsor
G
German Crohn's and Colitis Association (DCCV e.V.)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 on disease activity, intestinal inflammation and symptoms in IBD patients with chronic colitis? Ulcerative Colitis (UC) and Crohn's disease (MC) patients are recruited during an inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg, Germany. During their routine inpatient stay, patients are treated by an interdisciplinary team using a comprehensive multimodal integrative inpatient therapy concept that combines conventional medicine with a wide range of integrative non-pharmacological treatments, phytotherapy, lifestyle-modification and nutritional therapy. During this time, it is verified whether the patients can participate in the study. The study consists of two study arms, which are conducted in a cross-over design: * Intervention arm: in this study arm, participants receive 12 weeks of blueberry therapy in addition to the regular two weeks of inpatient care at the Clinic for Internal and Integrative Medicine in Bamberg. The blueberry therapy includes drinking around 35 g of blueberry powder stirred into water once a day for 12 weeks. * Control arm: in this study arm, participants receive the standard therapy (integrative medical therapy concept described above) during the regular two-week hospital stay. There is no additional blueberry intake. Due to the crossover study design, all participants undergo both study arms. This means that each participant takes the supplementary blueberry powder (intervention) for a period of 3 months and the control therapy for 3 months. The order in which the participants receive the forms of therapy is determined randomly. Thus, half of the study participants start the supplementary blueberry intake directly after the inpatient stay, the second half three months later (cross-over principle). UC and MC patients will: * initially receive a clinically indicated colonoscopy with confocal laser endomicroscopy (CLE) during their routine inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg * return to the clinic for an optional sigmoidoscopy with CLE after 12 and 24 weeks * answer questionnaires at study start as well as after 12 and 24 weeks to analyze their quality of life, the severity of their symptoms and their disease activity * give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during the colonoscopy/sigmoidoscopy at study start as well as after 12 and 24 weeks * document their intake of blueberry powder as well as their symptoms and stool frequencies in a diary throughout the study participation
CONDITIONS
Official Title
Wild Blueberries in Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis with mild to moderate colitis for at least 6 months
- Stable IBD-specific medication dose for at least 3 months (e.g., 5-aminosalicylates, thiopurines, biologicals)
- Inpatient admission to the Department for Internal and Integrative Medicine at Sozialstiftung Bamberg, Germany for treatment
- Clinical indication and performance of an initial colonoscopy with confocal laser endomicroscopy (CLE)
- Signed informed consent form
You will not qualify if you...
- IBD without colon inflammation (e.g., Crohn's Disease without colitis)
- Active flare of IBD
- CRP level equal to or greater than 100 mg/l
- Artificial bowel outlet before the colon (ileostomy)
- High regular consumption of blueberries (at least 300 g cultivated or 150 g wild blueberries per week) or 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 anthocyanins or fructose
- Presence of serious infectious diseases such as HIV, hepatitis B, or hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sozialstiftung Bamberg
Bamberg, Bavaria, Germany, 96049
Actively Recruiting
Research Team
A
Angelika Schmalzl, Dr. rer. nat.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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