Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-02 @ 6:32 AM
Study NCT ID:
NCT02161120
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-14', 'releaseDate': '2016-09-26'}], 'estimatedResultsFirstSubmitDate': '2016-09-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D053560', 'term': 'Ichthyosis Bullosa of Siemens'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007057', 'term': 'Ichthyosis'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-28', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change is IBS symptoms by using IBS-SSS questionaire', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'IBS quality of life by using IBS QoL questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Changes in specific IBS symptoms measured by 100 mm VAS scale', 'timeFrame': '4 weeks'}, {'measure': 'Changes is intestinal microbiota evaluated by fecal samples', 'timeFrame': '4 weeks'}, {'measure': 'Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '32153925', 'type': 'DERIVED', 'citation': 'Laatikainen R, Jalanka J, Loponen J, Hongisto SM, Hillila M, Koskenpato J, Korpela R, Salonen A. Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation. BMC Nutr. 2019 Mar 6;5:12. doi: 10.1186/s40795-019-0278-7. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS according to Rome III criteria. Accepted sub-types include IBS-M, IBS-D and IBS-U\n* Age 18-65 years\n* Willing to use rye bread daily during the study periods\n\nExclusion Criteria:\n\n* IBS-C (constipation dominant)\n* Celiac disease\n* IBD\n* Major gastrointestinal operations like bowel gastric resection\n* Non-treated hypo- or hyperthyroidism\n* Alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol\n* Regular (almost daily) use of NSAIDs, antibiotics or lactulose\n* Linaclotide and other prescription medicines targeted specifically to IBS\n* Pregnancy and lactation\n* Follows currently strict low-FODMAP diet'}, 'identificationModule': {'nctId': 'NCT02161120', 'briefTitle': 'Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oy Karl Fazer Ab'}, 'officialTitle': 'Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.', 'orgStudyIdInfo': {'id': 'BSTN-2014-rye'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional rye bread', 'description': 'As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily', 'interventionNames': ['Other: Traditional Finnish rye bread']}, {'type': 'EXPERIMENTAL', 'label': 'Low-FODMAP rye bread', 'description': 'As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily', 'interventionNames': ['Other: Low FODMAP rye bread']}], 'interventions': [{'name': 'Traditional Finnish rye bread', 'type': 'OTHER', 'armGroupLabels': ['Traditional rye bread']}, {'name': 'Low FODMAP rye bread', 'type': 'OTHER', 'armGroupLabels': ['Low-FODMAP rye bread']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Helsinki', 'state': 'Helsinki', 'country': 'Finland', 'facility': 'Aava Medical Centre', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oy Karl Fazer Ab', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-26', 'type': 'RELEASE'}, {'date': '2016-11-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Oy Karl Fazer Ab'}}}}