Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:17 AM
Study NCT ID:
NCT05972694
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Grapes in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 21 days. A stool and blood sample will be collected at the start and end of the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fecal microbiota composition', 'timeFrame': 'baseline (pre-intervention), immediately after the intervention', 'description': '16S microbiome'}], 'secondaryOutcomes': [{'measure': 'fecal myleoperoxidase (MPO)', 'timeFrame': 'baseline (pre-intervention), immediately after the intervention', 'description': 'fecal marker of inflammation'}, {'measure': 'fecal calprotectin', 'timeFrame': 'baseline (pre-intervention), immediately after the intervention', 'description': 'fecal marker of inflammation'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'baseline (pre-intervention), immediately after the intervention', 'description': 'blood marker of inflammation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.grapesfromcalifornia.com/', 'label': 'California Table Grape Commission'}]}, 'descriptionModule': {'briefSummary': "The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).", 'detailedDescription': "This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).\n\nThe overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease (CD).\n\nAn 28 day pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table\n\nParticipation in this study will last for a maximum of 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of Crohns disease. CD outpatients in remission\n* Harvey Bradshaw-index in remission (\\<6 score)\n* Capable of providing consent to participate.\n* Able to complete daily surveys and take oral nutrition\n* Able to record daily meal intake\n\nExclusion Criteria:\n\n* Short bowel syndrome.\n* Hospitalized patients.\n* Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.\n* Known drug abuse.\n* Known parasitic disease of the digestive system.\n* Symptomatic intestinal stricture.\n* Presence of an ostomy.\n* Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.\n* Well-founded doubt about the patients cooperation.\n* Existing pregnancy or lactation.\n* History of \\<1 natural bowel movements per day.\n* Unable to access to technology that permits the daily completion of study related activities.\n* Change in IBD medication within past 4 weeks.\n* Body mass Index \\<16 kg/m or ≥35.\n* Documented C.difficile colitis within four weeks of screening.\n* Known berry or grape allergy\n* No probiotic or antibiotic use for the previous 14 days'}, 'identificationModule': {'nctId': 'NCT05972694', 'briefTitle': 'Effect of Grapes in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'The Effect of Grapes in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'STUDY20230070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Freeze-dried Grape powder intervention', 'description': 'participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.', 'interventionNames': ['Dietary Supplement: Freeze dried grape powder']}], 'interventions': [{'name': 'Freeze dried grape powder', 'type': 'DIETARY_SUPPLEMENT', 'description': '46g/d freeze-dried grape powder', 'armGroupLabels': ['Freeze-dried Grape powder intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Abigail Basson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Table Grape Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}