NCT07421596 An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System

Eligibility & Interventions

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This trial targets 50 participants in total. It began in 2026-02-05 with a primary completion date of 2026-04-06.

Brief Summary

This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period. Gut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being. In this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires. Stool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being. The study will also monitor the safety and tolerability of the dietary supplement system during the study period.

Eligibility Criteria

Inclusion Criteria: * 1\. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening. 2\. Willing and able to provide written informed consent before participation in any study-related procedures. 3\. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points. 4\. Willing to collect and provide stool samples, either in-clinic or at home as instructed. 5\. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study. 6\. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone. 8\. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled. 9\. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol. 11\. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects). Exclusion Criteria: * 1\. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products. 2\. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to: * Malabsorption disorders * Chronic gastrointestinal diseases * Severe depression * Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report. 4\. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception. 5\. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment. 8\. History of weight loss surgery or any type of bowel surgery, including resection or colectomy. 9\. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization. 10\. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents. 11\. History of seizure disorder or use of seizure medication within the past 4 weeks. 12\. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to: * Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®) * Laxatives or gastrointestinal motility agents * Medications for irritable bowel syndrome (IBS), Crohn's disease, or history of hospitalized diverticulitis 14. Any other condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation or compromise subject safety or study integrity.

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