Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 3:55 PM
Study NCT ID:
NCT06779994
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Probiotic for Improving Intestinal and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double(Participant, investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antimicrobial peptide levels in stool samples', 'timeFrame': '8 weeks', 'description': 'Antimicrobial peptides refer to fecal calprotectin and LL-37(Cathelicidin Antimicrobial Peptide). The change in their concentrations at the end of the intervention was detected compared to baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adults Aged 18-45 Years']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Streptococcus salivarius subsp. thermophilus ST36 in healthy adults on immune function and intestinal health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\) Age 18-45 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Streptococcus salivarius subsp. thermophilus ST36/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention;\n\nExclusion Criteria:\n\n* 1\\) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past."}, 'identificationModule': {'nctId': 'NCT06779994', 'briefTitle': 'The Safety and Efficacy of Probiotic for Improving Intestinal and Immune Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'Safety and Efficacy of Streptococcus Salivarius Subsp. Thermophilus ST36 on Intestinal and Immune Function Improvement.', 'orgStudyIdInfo': {'id': 'WK2025002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': '30B CFU/strip/day ST36, before meals; Storage: Store in a cool, dry place without sun exposure.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Dextrin, one strip/day, before meals; Storage: Store in a cool, dry place without sun exposure.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study will last 8 weeks and each subject will have three visits (day 0, week 4 and week 8).', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study will last 8 weeks and each subject will have three visits (day 0, week 4 and week 8).', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210095', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Xu fei', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}