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.
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
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
Single group
Complete Commensal Probiotic
Dietary supplementComplete 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).
Relative Abundance of Commensal Microorganisms
Counts of microbes per gram of each organism on GI-MAP test
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
Gastrointestinal Symptoms Rating Scale
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
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
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.
This trial is not recruiting at the moment. You can still explore other options:
