Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT04757935
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2018-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Yoga for Youth With IBD: a Pilot Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], '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': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of acceptability', 'timeFrame': '1 hour focus group at conclusion of intervention.', 'description': 'Focus Group'}], 'secondaryOutcomes': [{'measure': 'Fecal Calprotectin', 'timeFrame': '6 weeks (Prior to intervention; After conclusion of intervention)', 'description': 'Stool biomarker that indicates intestinal inflammation'}, {'measure': 'Pediatric Ulcerative Colitis Activity Index', 'timeFrame': '6 weeks (Prior to intervention; After conclusion of intervention)', 'description': "5 question assessment tool for disease tracking for patient's with ulcerative colitis"}, {'measure': 'PROMIS-37', 'timeFrame': '6 weeks (Prior to intervention; After conclusion of intervention)', 'description': 'NIH Pediatric Assessment Tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammatory bowel disease', 'adolescent', 'yoga', 'mind-body'], 'conditions': ['Inflammatory Bowel Diseases', 'Yoga', 'Adolescents', 'Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.', 'detailedDescription': 'Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD.\n\nThe study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 10-21\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist\n* Ability to attend in-person meetings/training\n\nExclusion Criteria:\n\n* Initiation of biologic therapy in prior 3 months\n* Hospital admission in prior 2 months\n* Major surgery in prior 1 month\n* PUCAI/PCDAI \\>65\n* Current pregnancy\n* Severe developmental or intellectual disability\n* Non-english speaking\n* Not participating in another concurrent clinical trial"}, 'identificationModule': {'nctId': 'NCT04757935', 'briefTitle': 'Yoga for Youth With IBD: a Pilot Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'IRB Protocol 37755'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Ann Ming Yeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinician Educator at Stanford University'}, {'name': 'Jenna Marie Arruda, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}