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

NCT07720362 | Not Yet Recruiting

• 1 other identifier: DFH - 002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional and Microbial Markers of Intestinal Health

  Baseline and end of 8-week intervention

• Gastrointestinal Symptoms Rating Scale

  Baseline and end of 8-week intervention

• Digestion-Associated Quality of Life Questionnaire

  Assessed at baseline and end of 8-week study.

• PROMIS - Global Health

  Baseline and end of 8-week study.

• PROMIS - Anxiety Short Form 8a

  Assessed at baseline and end of 8-week study.

Study Arms (1)

Complete Commensal Probiotic

EXPERIMENTAL

Dietary Supplement: Complete Commensal Probiotic

Interventions

Complete Commensal Probiotic DIETARY_SUPPLEMENT

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).

Complete Commensal Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Severely immunocompromised status (e.g., active chemotherapy, post-transplant immunosuppression, advanced HIV)
• Participants unable to provide consent

Sponsors & Collaborators

• OvationLab: lead

Study Sites (1)

OvationLab

Richmond, Virginia, 23220, United States

Location

Central Study Contacts

Study Administrator

CONTACT

‪(240) 232-2103‬; info@ovationlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 22, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)