Not yet recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Complete Commensal Probiotic.
- Who it may be relevant to
- Registry conditions: Gastrointestinal, Microbiota. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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).
Primary outcome measures
- Relative Abundance of Commensal Microorganisms [Time frame: Baseline and end of 8-week intervention]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- OvationLab — Richmond
Identifiers
NCT: NCT07720362 · DFH - 002