Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:38 AM
Study NCT ID:
NCT07355634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terraflora Daily Care and Gastrointestinal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GA-Map Dysbiosis Test', 'timeFrame': '4 weeks, 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with dysfunction on GI360 Profile', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'Percentage of participants with dysfunction on Thorne Gut Health Test', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'Gastrointestinal Symptom Rating Scale', 'timeFrame': '4 weeks, 12 weeks', 'description': 'Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal']}, 'descriptionModule': {'briefSummary': 'A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult males or females age ≥ 25 years\n2. Ability to read and speak English\n3. Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)\n\nExclusion Criteria:\n\n1. Daily use within the past month of any probiotic or prebiotic supplement\n2. Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis\n3. Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications\n4. Current daily tobacco smoker\n5. Known allergies to any substance in the study products\n6. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks\n7. Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol\n8. Current participation in another clinical trial\n9. Participants unable to provide consent"}, 'identificationModule': {'nctId': 'NCT07355634', 'briefTitle': 'Terraflora Daily Care and Gastrointestinal Health', 'organization': {'class': 'NETWORK', 'fullName': 'OvationLab'}, 'officialTitle': 'A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health', 'orgStudyIdInfo': {'id': 'ENV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Terraflora - Daily Care', 'interventionNames': ['Dietary Supplement: Synbiotic Dietary Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Synbiotic Dietary Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks of supplementation with Enviromedica - Terraflora Daily Care', 'armGroupLabels': ['Terraflora - Daily Care']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Chris D'Adamo, Ph.D.", 'role': 'CONTACT', 'email': 'chris@ovationlab.com', 'phone': '240-232-2103'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OvationLab', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}