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Official title An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System
ClinicalTrials.gov ID: NCT07421596
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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%...
- 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...
- 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.
You likely can't join if
- 1\. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products. 2\. Presence or history of any medical...
- 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...
- Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)
See the full eligibility 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\. people with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 people) and score ≤ 3 (5 people).
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.