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

This is a prospective, open-label, single-arm clinical study designed to evaluate changes in gut and digestive health parameters following daily use of a dietary supplement system over an eight-week period.

Gut and digestive health are essential to overall human health and are closely associated with immune regulation, nutrient absorption, metabolic function, and systemic inflammation. The gastrointestinal tract contains a complex microbial ecosystem that supports digestion, produces bioactive metabolites, and modulates immune responses. Disruptions in gut microbiota composition, intestinal barrier integrity, and immune balance have been associated with digestive symptoms, inflammation, and reduced well-being.

This study will enroll approximately 50 adult male and female subjects between 18 and 80 years of age who meet all inclusion and exclusion criteria, including self-reported gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS). All participants will consume the study product daily for a total of eight weeks while maintaining their usual diet and lifestyle habits, as outlined in the protocol.

The dietary supplement system consists of two study products that contain a combination of plant-derived nutrients, fibers, probiotics, digestive enzymes, and antioxidant-rich botanical ingredients. These components are intended to support gut microbial diversity, digestive processes, immune balance, and intestinal barrier integrity.

Objective assessments of gut and digestive health will be conducted using stool-based laboratory evaluations at baseline and at the end of the study. These assessments include biomarkers related to microbial diversity, inflammation and immune activity (such as calprotectin, beta-defensin 2, and secretory IgA), digestive health markers (including short-chain fatty acids, bile acids, and malabsorption markers), and markers associated with intestinal barrier integrity and permeability.

Participant-reported outcomes will be collected using validated questionnaires, including the Gastrointestinal Symptom Rating Scale (GSRS) and a Subjective Digestive Health and Well-Being Questionnaire. These assessments will be administered at baseline and at regular intervals throughout the study to evaluate changes in gastrointestinal symptoms, digestive comfort, overall well-being, and product tolerability.

Safety assessments will be conducted throughout the study period, including monitoring of adverse events, concomitant medications, and study product compliance. The overall safety and tolerability of the dietary supplement system will be evaluated based on reported adverse events and clinical assessments.

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.

• Willing and able to provide written informed consent before participation in any study-related procedures.

• Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.

• Willing to collect and provide stool samples, either in-clinic or at home as instructed.

• Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.

• 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.

• Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.

• 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.

• 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.

• 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.

• 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.

• 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.

• History of weight loss surgery or any type of bowel surgery, including resection or colectomy.

• Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.

• Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.

• History of seizure disorder or use of seizure medication within the past 4 weeks.

• 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.