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Not Yet Recruiting NCT07720362

Open-Label Clinical Trial Evaluating the Impact of a Multi-Strain Commensal Probiotic Dietary Supplement on Gastrointestinal Microbiota Composition, Functional Gastrointestinal Markers, and Gastrointestinal Symptoms

Conditions: Gastrointestinal, Microbiota

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: OvationLab

Location: OvationLab Richmond Virginia

Summary

A single-arm, open-label prospective study will be conducted evaluating the impact of 8 weeks of supplementation at the manufacturer-recommended dose of Complete Commensal Probiotic™ on the GI-MAP stool test panel (Diagnostic Solutions Laboratory, Alpharetta, GA), gastrointestinal symptoms, digestion-associated quality of life. and overall physical health, mental health, and anxiety.

Eligibility Criteria

Inclusion Criteria: 1. Adult females or males age ≥ 18 years 2. At least moderate gastrointestinal distress, defined as a score of ≥ 4 on any domain of the Gastrointestinal Symptoms Rating Scale (GSRS) at screening 3. Ability to read and speak English 4. Ability and willingness to collect an at-home stool sample for GI-MAP testing Exclusion Criteria: 1. Current or recent (within the prior 90 days) use of a probiotic dietary supplement 2. Current or recent (within the prior 90 days) use of systemic antibiotics, antifungals, or antiparasitic medications 3. Known allergies to any ingredients in the product 4. Currently pregnant or lactating women or women planning to become pregnant in the next 8 weeks 5. Current diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis), celiac disease, active gastrointestinal malignancy, or other chronic health condition (e.g., cancer, heart failure, history of pancreatitis, type I or II diabetics on insulin) deemed clinically contraindicated for the study protocol 6. Severely immunocompromised status (e.g., active chemotherapy, post-transplant immunosuppression, advanced HIV) 7. Participants unable to provide consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07720362). StuddyBuddy aggregates publicly available trial information.