Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 11:10 AM
Study NCT ID:
NCT04520594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2020-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084922', 'term': 'Resistant Starch'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trail (OARS trial). Only Dr. Mack (Co-PI) can request to break the blind for safety reasons or eligibility for the OARS Trial; only Dr. Stintzi (Co-PI) will request to break the blind for interim analysis. Once the blind is broken, the patient will be discontinued from study product.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.', 'timeFrame': '6 ± 1 months'}, {'measure': 'Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.', 'timeFrame': '12 ± 2 months'}, {'measure': 'Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.', 'timeFrame': '6 ± 1 months and 12 ± 2 months'}], 'secondaryOutcomes': [{'measure': 'Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.', 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': 'The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.'}, {'measure': 'Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.', 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': 'The IMPACT III questionnaire (a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life.'}, {'measure': 'Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.', 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months'}, {'measure': "Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.", 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': "Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (\\<12.5 = remission, 12.5 to 40.0 = mild, \\>40.0 = moderate, \\>57.5 = severe)."}, {'measure': 'Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.', 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': 'The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (\\<10 = remission, 10 to 34 = mild, 35 to 64= moderate, \\>65 = severe).'}, {'measure': 'Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.', 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': 'The Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe).'}, {'measure': "Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.", 'timeFrame': 'Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months', 'description': 'The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistant Starch', 'Microbiome'], 'conditions': ['Crohn Disease', 'Ulcerative Colitis', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.\n* Enrolled in the main parent study.\n* Existing Crohn's disease or ulcerative colitis diagnosis.\n* In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month.\n* Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.\n* Willing to provide consent/assent for the collection of stool samples.\n\nExclusion Criteria:\n\n* Allergy to resistant starch or excipients.\n* Co-existing diagnosis with diabetes mellitus.\n* Treatment with another investigational drug or intervention throughout the study.\n* Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of an individual or legal guardian to give written informed consent.\n* Concomitant chronic disease requiring medications.\n* Requirement for antibiotic therapy \\>2 weeks duration.\n* Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.\n* Patients with previous intestinal surgery."}, 'identificationModule': {'nctId': 'NCT04520594', 'briefTitle': 'OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Eastern Ontario"}, 'officialTitle': 'OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial', 'orgStudyIdInfo': {'id': '20/16E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resistant Starch', 'description': 'Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months', 'interventionNames': ['Other: Resistant Starch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Resistant Starch', 'type': 'OTHER', 'description': '7.5 g resistant starch/m2 oral consumption', 'armGroupLabels': ['Resistant Starch']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo oral consumption of food-grade cornstarch', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'David Mack, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Eastern Ontario"}, {'name': 'Alain Stintzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Eastern Ontario", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, CHEO IBD Centre', 'investigatorFullName': 'David Mack', 'investigatorAffiliation': "Children's Hospital of Eastern Ontario"}}}}