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

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 Overview

• Status: Not yet recruiting
• Conditions: Microbiota; Gastrointestinal
• Intervention / Treatment: Dietary supplement: Complete Commensal Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Administrator; Phone Number: ‪(240) 232-2103‬; Email: info@ovationlab.com

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • OvationLab
      • Contact: Study Administration; Phone Number: ‪(240) 232-2103‬; Email: info@ovationlab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Complete Commensal Probiotic

Dietary supplement: Complete Commensal Probiotic; Complete Commensal Probiotic™ contains five established commensal strains selected for their documented physiologic roles in the healthy adult gut. The five commensal strains in the product in this study are Akkermansia muciniphila (TA09), Bifidobacterium adolescentis (TA38), Bifidobacterium longum (TA24), Faecalibacterium prausnitzii (TA35), and Roseburia intestinalis (TA08).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Abundance of Commensal Microorganisms	Counts of microbes per gram of each organism on GI-MAP test	Baseline and end of 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	Assessed at baseline and end of 8-week study.

Collaborators and Investigators

• Sponsor: OvationLab

Study record dates

Study Major Dates

• Study Start (Estimated): July 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DFH - 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publicly-available data repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No