Status:
RECRUITING
An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System
Lead Sponsor:
SF Research Institute, Inc.
Collaborating Sponsors:
Life Vantage
Conditions:
Gastrointestinal Symptoms
Digestive Health
Eligibility:
All Genders
18-80 years
Phase:
NA
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 a...
Detailed Description
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 p...
Eligibility Criteria
Inclusion Criteria:
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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:
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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:
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Malabsorption disorders
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Chronic gastrointestinal diseases
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Severe depression
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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:
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Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)
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Laxatives or gastrointestinal motility agents
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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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Key Trial Info
Start Date :
February 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07421596
Start Date
February 5 2026
End Date
April 21 2026
Last Update
February 24 2026
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94132