Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:26 AM
Study NCT ID:
NCT07462494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Intervention in Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in stool consistency', 'timeFrame': '4 weeks', 'description': 'Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Function']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-65 years.\n2. Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.\n3. Able to comply with the study protocol and complete the study procedures.\n4. Participants who have voluntarily signed the informed consent form.\n5. Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective contraception during this period.\n\n \\-\n\nExclusion Criteria:\n\n1. Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.\n2. Participants who plan to change their dietary habits during the study period.\n3. Patients with severe allergies or immunodeficiency.\n4. Women who are pregnant, breastfeeding, or planning to become pregnant.\n5. Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.\n6. Individuals who have used antibiotics within the past two weeks.\n7. Individuals with severe psychological or psychiatric disorders.\n8. Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.\n9. Any other participants considered unsuitable for participation in the study by the investigator.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT07462494', 'briefTitle': 'Probiotic Intervention in Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'Clinical Study of Probiotic Intervention in Patients With Constipation: Evaluation of Gastrointestinal Function, Immunity, and Bone Metabolism', 'orgStudyIdInfo': {'id': 'WK20260304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'Probiotic powder containing Bifidobacterium animalis subsp. lactis BLa36 (3 g per pack) administered orally once daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: BLa36']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Maltodextrin powder (3 g per pack) administered orally once daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'BLa36', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taken orally once daily for 4 weeks.', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taken orally once daily for 4 weeks.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ying Jin, Doctor', 'role': 'CONTACT', 'email': 'sunny13211@sina.com', 'phone': '13375163966'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}