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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOvationLab

About this trial

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

Qualifiers

Adult females or males age ≥ 18 years

At least moderate gastrointestinal distress, defined as a score of ≥ 4 on any domain of the Gastrointestinal Symptoms Rating Scale (GSRS) at screening

Ability to read and speak English

Ability and willingness to collect an at-home stool sample for GI-MAP testing

Disqualifiers

Current or recent (within the prior 90 days) use of a probiotic dietary supplement

Current or recent (within the prior 90 days) use of systemic antibiotics, antifungals, or antiparasitic medications

Known allergies to any ingredients in the product

Currently pregnant or lactating women or women planning to become pregnant in the next 8 weeks

Trial design

Treatments tested in this trial

  • Complete Commensal Probiotic

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators