Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT06306469
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the changes in gut and oral microbiome profile of the participants during retreat', 'timeFrame': 'Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days', 'description': 'Stool and oral samples were collected from the participants for three timepoints (T1: 1 day, T2: 3-5 days, and T3: 7-9 days) and changes in gut microbiome and oral microbiome were assessed through 16S rRNA gene amplicon sequencing. T1 was considered as baseline data.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'meditation', 'arhatic yoga', 'beneficial microbes'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38307809', 'type': 'BACKGROUND', 'citation': 'Hammerschlag R, Sprengel ML, Baldwin AL. Biofield therapies: Guidelines for reporting clinical trials. Complement Ther Med. 2024 Jun;82:103011. doi: 10.1016/j.ctim.2023.103011. Epub 2024 Feb 1.'}, {'pmid': '37020274', 'type': 'BACKGROUND', 'citation': 'Raman M, Vishnubhotla R, Ramay HR, Goncalves MCB, Shin AS, Pawale D, Subramaniam B, Sadhasivam S. Isha yoga practices, vegan diet, and participation in Samyama meditation retreat: impact on the gut microbiome & metabolome - a non-randomized trial. BMC Complement Med Ther. 2023 Apr 5;23(1):107. doi: 10.1186/s12906-023-03935-8.'}, {'pmid': '29306937', 'type': 'BACKGROUND', 'citation': 'Househam AM, Peterson CT, Mills PJ, Chopra D. The Effects of Stress and Meditation on the Immune System, Human Microbiota, and Epigenetics. Adv Mind Body Med. 2017 Fall;31(4):10-25.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.\n\nThis study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being.', 'detailedDescription': 'The present study was designed as a single-arm pilot scale to understand the temporal changes in both gut and oral microbiome of the practitioners at a meditation-cum-spiritual retreat in a controlled environment. There was open communication between all the participants before, during and after the retreat. As all the practitioners followed group practices in one location under the supervision of the senior instructors, separate assessment of the adherence of the practitioners to the protocol was not performed. Oral and fecal samples of practitioners were collected at the start (Day0: T1), middle (Day3-5: T2) and end (Day7-9:T3) of the retreat in a sterile containers. Amplicon sequencing was performed from extracted DNA to study changes in microbiome profile during retreat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must provide written informed consent prior to initiation of any study procedures\n* was able to understand and agreed to comply with planned study procedures (agreed to the collection of specimens (saliva and fecal) before, during and after the study\n* male or non-pregnant female greater than 18 years of age at time of enrolment\n* must have a distinct Arhatic level (0-5 level) and performed meditation and MTH practices from once a week to more than 3 times a week prior to this retreat\n\nExclusion Criteria:\n\n* concomitant disease that requires any medical treatment\n* pregnancy\n* any antibiotic treatment in the past two weeks\n* pediatric population\n* clinical apparent infectious disease'}, 'identificationModule': {'nctId': 'NCT06306469', 'briefTitle': 'Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment', 'organization': {'class': 'OTHER', 'fullName': 'Pranic Healing Research Institute'}, 'officialTitle': 'Changes in Microbiota and Biochemical Markers in Healthy Subjects Before and After Meditation Practices in a Controlled Environment', 'orgStudyIdInfo': {'id': 'PHRI-2022-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single Arm1', 'description': 'All practitioners had undertaken formal training on Pranic Healing, Meditation on Twin Hearts, and higher meditation practices at least six months prior to the retreat. Daily retreat practices, which lasted typically for 16-18 hours with occasional short breaks. These practices included combinations of specifically designed physical and breathing exercises to improve the energetic states and stillness. Exercises were followed by Pranic Healing and self-awareness practices. Meditations included Meditation on Twin Hearts, Arhatic Yoga meditations of Kundalini meditation, Arhatic Dhyan and Meditation on the Higher Soul .', 'interventionNames': ['Other: Meditation practice']}], 'interventions': [{'name': 'Meditation practice', 'type': 'OTHER', 'description': 'physical and breathing exercises', 'armGroupLabels': ['single Arm1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07071', 'city': 'Lyndhurst', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pranic Healing Research Institute', 'geoPoint': {'lat': 40.81204, 'lon': -74.12431}}], 'overallOfficials': [{'name': 'Glenn Mendoza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pranic Healing Research Institute,New Jersey, 07071, USA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After publication, raw amplicon data will be available in NCBI for a very long time', 'ipdSharing': 'YES', 'description': 'Share the study protocol as well as raw data generated for amplicon sequencing', 'accessCriteria': 'Bioproject ID from NCBI will be described in publication. Researchers can use that ID and download or see the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pranic Healing Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}