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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OvationLab

Richmond, Virginia, 23220, United States

Location contact

Study Administration

CONTACT

[email protected]

‪(240) 232-2103‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Relative Abundance of Commensal Microorganisms

    Time frame: Baseline and end of 8-week intervention

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

Secondary outcomes

  1. Functional and Microbial Markers of Intestinal Health

    Time frame: Baseline and end of 8-week intervention

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

  2. Gastrointestinal Symptoms Rating Scale

    Time frame: Baseline and end of 8-week intervention

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

  3. Digestion-Associated Quality of Life Questionnaire

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

    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.

  4. PROMIS - Global Health

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

    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.

  5. PROMIS - Anxiety Short Form 8a

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Administrator

CONTACT

[email protected]

‪(240) 232-2103‬

Sponsors and collaborators

Lead sponsor

OvationLab

Network

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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