GastrointestinalNCT07720362
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 study testing Complete Commensal Probiotic in people with Gastrointestinal and Microbiota, run by OvationLab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal, Microbiota
- What is being tested?
- Complete Commensal Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OvationLab
Richmond, Virginia, 23220
Study Administration, (240) 232-2103, info@ovationlab.com
About this study
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
- Being tested
- Complete Commensal Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Commensal ProbioticDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Complete Commensal Probiotic | Experimental | Not described Receives: Dietary Supplement: Complete Commensal Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Abundance of Commensal Microorganisms
Counts of microbes per gram of each organism on GI-MAP test
Measured: Baseline and end of 8-week intervention
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline and end of 8-week study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start21 Jul 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OvationLab
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720362
- Sponsor's protocol ID
- DFH - 002
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publicly-available data repository
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07720362
- Acronym / sponsor ID
- DFH - 002
- Conditions
- Gastrointestinal, Microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- OvationLabResearch network
- Study start
- 21 Jul 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete Commensal Probiotic | Experimental | Dietary Supplement: Complete Commensal Probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Commensal ProbioticComplete 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). | Dietary supplement | Complete Commensal Probiotic |
Primary outcome
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
5 secondary outcomes
Functional and Microbial Markers of Intestinal Health
Time frame: Baseline and end of 8-week intervention
Gastrointestinal Symptoms Rating Scale
Time frame: Baseline and end of 8-week intervention
Digestion-Associated Quality of Life Questionnaire
Time frame: Assessed at baseline and end of 8-week study.
PROMIS - Global Health
Time frame: Baseline and end of 8-week study.
PROMIS - Anxiety Short Form 8a
Time frame: Assessed at baseline and end of 8-week study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. Publicly-available data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Commensal Probiotic in people with Gastrointestinal and Microbiota, run by OvationLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Administrator ((240) 232-2103, info@ovationlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Abundance of Commensal Microorganisms (time frame: Baseline and end of 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.