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

N/ANot Yet RecruitingNCT07720362

OvationLab25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gastrointestinal Microbiota

Interventions

Complete Commensal Probiotic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Relative Abundance of Commensal Microorganisms

Counts of microbes per gram of each organism on GI-MAP test

Time frame: Baseline and end of 8-week intervention

Secondary Outcomes

Functional and Microbial Markers of Intestinal Health

Functional and microbial markers of intestinal health on the GI-MAP will be categorized as low, medium, and high

Time frame: Baseline and end of 8-week intervention

Gastrointestinal Symptoms Rating Scale

Validated questionnaire assessing gastrointestinal symptoms. Total scores across all domains range from 15-105. Higher scores indicate worse gastrointestinal symptoms.

Time frame: Baseline and end of 8-week intervention

Digestion-Associated Quality of Life Questionnaire

Validated questionnaire assessing the impact of digestion on quality of life. Total scores across all domains range from 0 to 81. Higher scores indicate worse digestion-associated quality of life.

Time frame: Assessed at baseline and end of 8-week study.

PROMIS - Global Health

Validated questionnaire assessing global physical and mental health. T scores range from 16.2 to 67.7 for physical health and from 21.2 to 67.6 for mental health. Higher scores indicate better physical and mental health.

Time frame: Baseline and end of 8-week study.

PROMIS - Anxiety Short Form 8a

Validated questionnaire assessing feelings of anxiety. T scores range from 37.1 to 83.1. Higher scores indicate greater feelings of anxiety.

Time frame: Assessed at baseline and end of 8-week study.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts