Status:
COMPLETED
Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome
Lead Sponsor:
Helse Møre og Romsdal HF
Collaborating Sponsors:
Haukeland University Hospital
University of Bergen
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the ...
Detailed Description
Previous studies performed in rodents have found that hydrolyzed proteins from fish alters the lipid and cholesterol metabolism, reduce plasma cholesterol and triglyceride levels and alters the fatty ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Body mass index (BMI) 18-30 kg/m2
- Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria
Exclusion
- Suspected allergies against fish or shellfish
- Low or unstable blood pressure
- Diabetes mellitus pharmacologically treated
- Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation
- Acute infections (may be reconsidered for inclusion at a later time)
- Substance misuse
- Inability or unwillingness to comply with the requirements of study procedures
- Individuals in the middle of testing different dietary strategies for the treatment of IBS (such as the low-FODMAP diet) and/or not willing to/able to maintain a stable diet throughout the study period
- Use of pro- or prebiotic supplements
- Use of antibiotic treatment for the last 4 weeks
- Immunocompromised patient defined as taking immuno-suppressive medications
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03801057
Start Date
January 14 2019
End Date
April 21 2019
Last Update
August 14 2019
Active Locations (2)
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1
Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund, Norway
2
Haukeland University Hospital
Bergen, Norway