Gastrointestinal, Microbiota
Conditions
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.
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).
Sponsors
OvationLab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Abundance of Commensal Microorganisms | Baseline and end of 8-week intervention | Counts of microbes per gram of each organism on GI-MAP test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional and Microbial Markers of Intestinal Health | 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 |
| Gastrointestinal Symptoms Rating Scale | 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. |
| Digestion-Associated Quality of Life Questionnaire | 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. |
| PROMIS - Global Health | 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. |
| PROMIS - Anxiety Short Form 8a | 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. |
Countries
United States
Contacts
CONTACTStudy Administrator
Outcome results
None listed