[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720362":3,"trial-entities:NCT07720362":87,"trial-summary:NCT07720362":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":57,"minimum_age":58,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":81,"overall_officials":84,"references":85,"see_also_links":86},"NCT07720362","DFH - 002","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","NOT_YET_RECRUITING","2026-11","2026-07","2026-07-23","2026-07-21","OvationLab","NETWORK",false,"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.",null,[18,19],"Gastrointestinal","Microbiota",[],"INTERVENTIONAL","OTHER",[24],"NA",{"count":26,"type":27},25,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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).",[31],[35],{"measure":36,"description":37,"timeFrame":38},"Relative Abundance of Commensal Microorganisms","Counts of microbes per gram of each organism on GI-MAP test","Baseline and end of 8-week intervention",[40,43,46,50,54],{"measure":41,"description":42,"timeFrame":38},"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",{"measure":44,"description":45,"timeFrame":38},"Gastrointestinal Symptoms Rating Scale","Validated questionnaire assessing gastrointestinal symptoms. Total scores across all domains range from 15-105. Higher scores indicate worse gastrointestinal symptoms.",{"measure":47,"description":48,"timeFrame":49},"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.","Assessed at baseline and end of 8-week study.",{"measure":51,"description":52,"timeFrame":53},"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.","Baseline and end of 8-week study.",{"measure":55,"description":56,"timeFrame":49},"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.","ALL","18 Years",{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Adult females or males age ≥ 18 years\n2. At least moderate gastrointestinal distress, defined as a score of ≥ 4 on any domain of the Gastrointestinal Symptoms Rating Scale (GSRS) at screening\n3. Ability to read and speak English\n4. Ability and willingness to collect an at-home stool sample for GI-MAP testing\n\nExclusion Criteria:\n\n1. Current or recent (within the prior 90 days) use of a probiotic dietary supplement\n2. Current or recent (within the prior 90 days) use of systemic antibiotics, antifungals, or antiparasitic medications\n3. Known allergies to any ingredients in the product\n4. Currently pregnant or lactating women or women planning to become pregnant in the next 8 weeks\n5. 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\n6. Severely immunocompromised status (e.g., active chemotherapy, post-transplant immunosuppression, advanced HIV)\n7. Participants unable to provide consent",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":12,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Richmond","Virginia","23220","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Study Administration","CONTACT","‪(240) 232-2103‬","info@ovationlab.com",{"lat":79,"lon":80},37.55376,-77.46026,[82],{"name":83,"role":75,"phone":76,"email":77},"Study Administrator",[],[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Functional disorder of gastrointestinal tract",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an open-label study, meaning you and the researchers will know you are receiving the Complete Commensal Probiotic™. It's a single-arm study, so everyone receives the same intervention. About 25 people are expected to participate.","completed","Probiotic Supplement for Gastrointestinal Health","This study is looking at how a dietary supplement called Complete Commensal Probiotic™ affects your gut bacteria (microbiota) and digestive symptoms. It contains five specific types of beneficial bacteria. You might be able to join if you are an adult, at least 18 years old, and experience at least moderate gastrointestinal (GI) distress. The study will measure changes in your gut bacteria at the beginning and after 8 weeks of taking the supplement to see if it helps. The current status of this study is unclear.","Your gut bacteria will be measured at the end of the 8-week intervention. No further follow-up is specified.",86,"You would take the Complete Commensal Probiotic™ for 8 weeks. You will also need to provide an at-home stool sample for testing at the beginning and end of the study.","Not stated in the trial record.",[31],"v2"]