Wild Blueberries in Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Duisburg-Essen
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
blueberry-rich diet
Dietary supplementThe 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 morning for a period of 12 weeks.
Control diet
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of the intestinal inflammation status evaluated via fecal calprotectin levels
The inflammation status is evaluated through measurement of fecal calprotectin levels in stool samples. This biomarker provides information about the inflammatory status in the intestine and serves as an objective measure of disease activity.
Time frame
week 0, 12, 24Secondary outcomes
1
Improvement of Crohn's disease severity evaluated by Harvey-Bradshaw-Index (HBI)
The disease severity of CD patients is evaluated via a validated questionnaire that is specific for Crohn's Disease (Harvey-Bradshaw-Index): The HBI was designed as a simplified version of the CDAI to enable systematic collection of clinical data on Crohn's disease and is used to assess the degree of illness in individuals with Crohn's disease. The index considers five, exclusively clinical parameters. A specific score is assigned for each parameter. To assess disease activity, the sum score is formed from questions on general condition, abdominal pain, number of unformed bowel movements per day, abdominal resistance and complications. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.
Time frame
week 0, 12, 242
Improvement of ulcerative colitis disease severity evaluated by MAYO-Score
The disease severity of UC patients is evaluated via a validated questionnaire that is specific for ulcerative colitis (MAYO-Score): The Mayo Score is the most commonly used scoring system for UC in clinical trials and routine practice. It was developed to standardize the severity of a patient's UC symptoms, which is particularly helpful to assess response to treatment over time. For this study, the partial MAYO-Score, which comprises only the non-invasive components of the full Mayo score, as well as the endoscopic subscore are applied. The partial MAYO-Score considers three clinical parameters, each of which is assigned a score from 0 to 3 leading to a maximum score of 9 points. Clinical response is defined as a decrease of at least 2 points. The partial MAYO-Score in combination with the endoscopic subscore are used to assess the patients' disease activity.
Time frame
week 0, 12, 243
Evaluation of IBD-SI (Inflammatory Bowel Disease Symptom Inventory)
The IBD-SI combines items from existing clinician-rated or diary-format inventories. After factor analysis, 38 items were retained on 5 subscales: bowel symptoms, abdominal discomfort, fatigue, bowel complications, and systemic complications. A total score as well as subscale scores will be calculated.
Time frame
week 0, 12, 244
Evaluation of disease-specific quality of life by IBD-Q (Inflammatory Bowel Disease Questionnaire)
The IBD-Q is the most frequently used questionnaire for disease-specific quality of life in clinical studies on Crohn's disease. It operationalizes quality of life on 4 dimensions (emotional and social impairment as well as bowel-related and systemic symptoms), in addition to a sum score. Answers are recorded on a 7-point Likert scale. High values mean good, low values a reduced quality of life (1=worst score, 7=best score). The total IBD-Q scale ranges from 32 to 224. A score of ≥ 170 can be considered as normal quality of life.
Time frame
week 0, 12, 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität Duisburg-Essen
Lead sponsor
German Crohn's and Colitis Association (DCCV e.V.)
Collaborator
Wilhelm Doerenkamp Foundation
Collaborator
Source ClinicalTrials.gov