Wild Blueberries in Colitis

Study acronym: BlueVantage
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Aug 2026 → Jan 2028
See other at-risk trials from Universität Duisburg-Essen

Record History

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  1. Notable Primary completion pushed from Aug 2026 to Jan 2028 Show 7 more changesShow less
    • Start date: Sep 24, 2024 to Dec 5, 2024
    • Study completion pushed from Apr 2027 to Jul 2028
    • Eligibility criteria expanded, about 66 words
    • Secondary endpoints: details revised at 23 of 35 entries
    • Study description expanded, about 25 words
    • Site contact updated
    • Collaborators: details revised at 1 of 2 entries
  2. Minor Site contact updatedv3
  3. Minor Secondary endpoints: 30 to 35
    • Eligibility criteria shortened, about 1 word
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06698601
Lead Sponsor Universität Duisburg-Essen
Collaborators: German Crohn's and Colitis Association (DCCV e.V.), Wilhelm Doerenkamp Foundation
Conditions
(from sponsor)
Ulcerative Colitis (UC), Crohn Disease (CD)
Related terms Colitis, Ulcerative, Crohn Disease, Inflammation, Inflammatory Bowel Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov