- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801057
Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome (MPH_IBS)
The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 acid composition in liver and adipose tissue. Previous studies in humans have found marine peptides to have both antihypertensive and antioxidant effects. It is also suggested that fish protein hydrolysates may have an immunomodulating effect with beneficial properties in the intestine, and may prevent NSAID-induced injuries, change permeability in the gut and possibly prevent injurious conditions in the gut.
The evidence and knowledge are limited on the interaction between diet, gut microbiota and the influence of specific nutrients, as well as the impact of different sources of proteins on inflammation markers, gut microbiota and symptom severity in patients with irritable bowel syndrome (IBS). Different dietary sources of protein affect the diversity and composition of the human gut microbiota in different degree, demonstrated by a distinct gut bacteria profile observed between omnivores and vegetarians.The specific effect of marine peptides on human gut microbiota composition is as far as the investigators know, previously not investigated. Interestingly, novel results indicate that the presence of fish proteins in the diet have impact on both composition and activity of the gut microbiome, influencing the human microbiota composition.
The many benefits of expanding the utilization of marine products, the previous assumed beneficial intestinal effect and the increased interest in gut health and microbiota, as well as a great need for novel dietary treatment strategies for patients with irritable bowel syndrome (IBS) make this study warrant.
Aim with this trial is to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in human subjects diagnosed with IBS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bergen, Norway
- Haukeland University Hospital
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Ålesund, Norway
- Ålesund Hospital, Helse Møre og Romsdal HF
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- Body mass index (BMI) 18-30 kg/m2
- Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: MPH_active
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH).
Random sequence of arms.
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One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks.
The form is powder, flavored with lemon, and to be mixed with 100 ml water.
Random sequence of arms.
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Placebo Comparator: MPH_placebo
Daily intake at breakfast of supplementary placebo.
Random sequence of arms.
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One daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks.
The form is powder, flavored with lemon, and to be mixed with 100 ml water.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBS-SSS
Time Frame: Before (baseline) and after intervention (6 weeks later).
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A decrease of 50 points or more in IBS-SSS, which is a clinically meaningful improvement.The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days.
Subjects respond to each question on a 100-point visual analogue scale.
Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms.
Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS.
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Before (baseline) and after intervention (6 weeks later).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-NDI_HRQOL
Time Frame: Before (baseline) and after intervention (6 weeks later).
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The Short Form (SF) Nepean Dyspepsia Index is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in patients, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items .
Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely).
Individual items in each sub-scale are aggregated to obtain a score range from 0 (lowest HRQoL score) to 100 (highest HRQoL score) as per the developers' original calculation formula.
A total, overall SF-NDI total score is obtained using the mean of 5 subscale scores.
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Before (baseline) and after intervention (6 weeks later).
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Fecal Calprotectin
Time Frame: Before (baseline) and after intervention (6 weeks later).
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Calprotectin is a protein found in several human fluids.
When detected in the stool, calprotectin has a direct relationship (consequence of neutrophil degranulation) to inflammation in the bowel.
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Before (baseline) and after intervention (6 weeks later).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory markers in blood
Time Frame: Before (baseline) and after intervention (6 weeks later).
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Zonulin, iFABP (intestinal fatty acid binding protein), LBP (lipopolysaccharide binding protein), IL-4, 6, 8, 10, TNF-α and INF-γ are markers of bowel mucosal damage.
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Before (baseline) and after intervention (6 weeks later).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dag Arne Lihaug Hoff, MD, PhD, Helse Møre og Romsdal Hospital Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/1825
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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