Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-03-23 @ 9:13 AM
Study NCT ID:
NCT03801057
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel group randomized, controlled clinical trial for six weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory markers in blood', 'timeFrame': 'Before (baseline) and after intervention (6 weeks later).', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'IBS-SSS', 'timeFrame': 'Before (baseline) and after intervention (6 weeks later).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'SF-NDI_HRQOL', 'timeFrame': 'Before (baseline) and after intervention (6 weeks later).', 'description': "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."}, {'measure': 'Fecal Calprotectin', 'timeFrame': 'Before (baseline) and after intervention (6 weeks later).', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary Supplements', 'Fish Proteins', 'Protein Hydrolysates'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '31319590', 'type': 'RESULT', 'citation': 'Dale HF, Jensen C, Hausken T, Valeur J, Hoff DAL, Lied GA. Effects of a Cod Protein Hydrolysate Supplement on Symptoms, Gut Integrity Markers and Fecal Fermentation in Patients with Irritable Bowel Syndrome. Nutrients. 2019 Jul 17;11(7):1635. doi: 10.3390/nu11071635.'}]}, 'descriptionModule': {'briefSummary': '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 scientific validity of such products is limited. However, there is sufficient preliminary data to indicate that bioactive compounds may be novel for potentially clinical use, thus further clinical trials investigating effect are needed. This trial is meant to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in people diagnosed with irritable bowel syndrome.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nAim 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Body mass index (BMI) 18-30 kg/m2\n* Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria\n\nExclusion Criteria:\n\n* Suspected allergies against fish or shellfish\n* Low or unstable blood pressure\n* Diabetes mellitus pharmacologically treated\n* Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation\n* Acute infections (may be reconsidered for inclusion at a later time)\n* Substance misuse\n* Inability or unwillingness to comply with the requirements of study procedures\n* 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\n* Use of pro- or prebiotic supplements\n* Use of antibiotic treatment for the last 4 weeks\n* Immunocompromised patient defined as taking immuno-suppressive medications'}, 'identificationModule': {'nctId': 'NCT03801057', 'acronym': 'MPH_IBS', 'briefTitle': 'Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Møre og Romsdal HF'}, 'officialTitle': 'The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '2018/1825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MPH_active', 'description': 'Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.', 'interventionNames': ['Dietary Supplement: MPH_active']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MPH_placebo', 'description': 'Daily intake at breakfast of supplementary placebo. Random sequence of arms.', 'interventionNames': ['Dietary Supplement: MPH_placebo']}], 'interventions': [{'name': 'MPH_active', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['MPH_active']}, {'name': 'MPH_placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['MPH_placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Ålesund Hospital, Helse Møre og Romsdal HF', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Dag Arne Lihaug Hoff, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helse Møre og Romsdal Hospital Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}