Wild Blueberries in Colitis

NCT06698601 | Recruiting

• 1 other identifier: 23068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ulcerative Colitis (UC); Crohn Disease (CD)

Keywords

ulcerative colitis; crohn disease; integrative medicine; intestinal barrier; inflammatory bowel disease; confocal laser endomicroscopy; wild blueberry; bilberry; nutrition; microbiome; inflammation; chronic colitis

Outcome Measures

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.

  week 0, 12, 24

Secondary Outcomes (35)

• Improvement of Crohn's disease severity evaluated by Harvey-Bradshaw-Index (HBI)

  week 0, 12, 24

• Improvement of ulcerative colitis disease severity evaluated by MAYO-Score

  week 0, 12, 24

• Evaluation of IBD-SI (Inflammatory Bowel Disease Symptom Inventory)

  week 0, 12, 24

• Evaluation of disease-specific quality of life by IBD-Q (Inflammatory Bowel Disease Questionnaire)

  week 0, 12, 24

• Assessment of health-related quality of life with the Short Form 12 Health Survey (SF-12)

  week 0, 12, 24

Study Arms (2)

Intervention group

EXPERIMENTAL

wild blueberry

Dietary Supplement: blueberry-rich diet

Control group

OTHER

No wild blueberry

Other: Control diet

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 morning for a period of 12 weeks.

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) with mild to moderate colitis for at least 6 months (CD: Harvey-Bradshaw-Index Score 5-16; UC: Partial Mayo Score 2-6)
• stable IBD-specific medication dosage for at least 3 months \[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\]
• 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)
• signed informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Universität Duisburg-Essen: collaborator
• German Crohn's and Colitis Association (DCCV e.V.): collaborator
• Wilhelm Doerenkamp Foundation: collaborator

Study Sites (1)

Sozialstiftung Bamberg

Bamberg, Bavaria, 96049, Germany

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Inflammation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jost Langhorst, Univ. Prof. Dr. med.

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelika Schmalzl, Dr. rer. nat.

CONTACT

0049 951 503 11650; FIGN@sozialstiftung-bamberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr. med

Model Details: All participants undergo both study arms. This means that each participant is in the blueberry (intervention) group for a period of 3 months and is in the control group 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 (crossover design).

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)