Status:
UNKNOWN
Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
Lead Sponsor:
Brain-Gut Research Group
Collaborating Sponsors:
Aalborg University
Maastricht University Medical Center
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
There is extensive pre-clinical evidence for potential health effects of blueberries. These are related, but not exclusively due to their high polyphenol content. This translational, clinical, randomi...
Eligibility Criteria
Inclusion
- Fifty-five successive male or female patients with Functional Gastrointestinal Disorders FGID) enrolled from our Gastroenterology Group Practice (GGP) in Bern, Switzerland, classified as having either Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or both according to Rome 4 criteria (Drossman et al 2016; Schmulson et al. 2017)
- Age between 18 and 50 years
- Body mass index 18.5-29.9 kg/m2
- European / Caucasian ethnicity
- Able to give informed consent in German as documented by signature
Exclusion
- Evidence of clinically significant disease, as assessed by usual clinical practice (history, blood and stool tests, imaging and endoscopy, as clinically required) and by investigator.
- Colonoscopy, antibiotics or probiotics within 2 weeks before or during the study.
- Planned dietary modifications (including polyphenol-rich fruit or vegetable smoothies, drinks or diets) or initiation of new treatments during the study period, besides the study interventions.
- Inability or contraindications to undergo the investigated intervention
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04824976
Start Date
January 1 2020
End Date
April 1 2022
Last Update
April 1 2021
Active Locations (1)
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1
Gastroenterology Group Practice / Brain-Gut Research Group
Bern, Switzerland, 3011