CClinicalTrials.gg
Not yet recruitingNCT07720362Updated Jul 23, 2026

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

An interventional study of Complete Commensal Probiotic in Gastrointestinal and Microbiota, sponsored by OvationLab. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by OvationLab · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Gastrointestinal
  • Microbiota
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In context

Lead sponsor

OvationLab is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Complete Commensal Probiotic

    Dietary Supplement: Complete Commensal Probiotic

Interventions

  • Dietary supplementComplete 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).

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What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

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Study locations

1 site
  • OvationLab
    Richmond, Virginia 23220, United States
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References and documents

Individual participant data

Plan to share: Yes — Publicly-available data repository

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07720362
Lead sponsor
OvationLab
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Jul 21, 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 23, 2026

Study contacts

Study Administrator
Contact
info@ovationlab.com
‪(240) 232-2103‬

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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