Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
Study NCT ID:
NCT03225261
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2017-06-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Citrus Extract on Gastrointestinal Health
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716707', 'term': 'grapefruit seed extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect on intestinal inflammation, measured by fecal calprotectin levels.', 'timeFrame': '8 weeks', 'description': 'The primary objective is to assess the effect of 500 mg citrus extract on intestinal flammation after 8 weeks of administration, by measuring fecal calprotectin in IBS patients with moderately increased fecal calprotectin levels.'}], 'secondaryOutcomes': [{'measure': 'The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).', 'timeFrame': '8 weeks'}, {'measure': 'The effect on fecal microbiota composition, assessed by next generation sequencing.', 'timeFrame': '8 weeks'}, {'measure': 'The effect on fecal microbiota functional capacity, assessed by next generation sequencing.', 'timeFrame': '8 weeks'}, {'measure': 'The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood', 'timeFrame': '8 weeks'}, {'measure': 'The effect on disease symptoms, measured by patient reported outcomes (GSRS).', 'timeFrame': '8 weeks'}, {'measure': 'The effect on disease symptoms, measured by patient reported outcomes (symptom diary).', 'timeFrame': '8 weeks'}, {'measure': 'The effect on stool frequency, measured by Bristol Stool Chart.', 'timeFrame': '8 weeks'}, {'measure': 'The effect on stool consistency, measured by Bristol Stool Chart.', 'timeFrame': '8 weeks'}, {'measure': 'The effect on blood markers for oxidative stress, measured by MDA concentration in blood.', 'timeFrame': '8 weeks'}, {'measure': 'The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with IBS\n* Calprotectin levels 15-150 µg/g feces\n* Age 18-70 years\n* BMI \\< 35 kg/m2\n\nExclusion Criteria:\n\n* Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)\n* Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)\n* Use of immunosuppressive drugs within 3 months before study period\n* Use of other medication interfering with endpoints\n* Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study\n* Changes in clinical activity scores within 3 weeks prior to the study\n* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study\n* Use of dietary supplements containing antioxidants, minerals and vitamins\n* Excessive intake of foods with a high polyphenol concentration\n* Use of antibiotics within 3 months prior to the start of study\n* Use of pre-or probiotics within 1 month prior to the study\n* Use of oral corticosteroids within 1 month prior to the study\n* Blood donation within 1 month prior to the study\n* Known pregnancy or lactation.\n* Excessive drinking (\\>20 alcoholic consumptions per week)\n* History of any side effects towards the intake of flavonoids or citrus fruits"}, 'identificationModule': {'nctId': 'NCT03225261', 'briefTitle': 'The Effect of Citrus Extract on Gastrointestinal Health', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Citrus Extract Administration on Gastrointestinal Health', 'orgStudyIdInfo': {'id': '173003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citrus extract', 'description': 'Citrus extract', 'interventionNames': ['Dietary Supplement: Citrus extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Citrus extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Citrus extract', 'armGroupLabels': ['Citrus extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Ad Masclee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc.', 'investigatorFullName': 'Yala Stevens', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}