8-week daily supplement program to support gut and digestive health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, single-arm study in which about 50 adults aged 18–80 with self-reported gastrointestinal symptoms will take two study products (PhytoPower 1 and PhytoPower 2) daily for eight weeks while keeping their usual diet and lifestyle. Stool samples and symptom questionnaires (including the GSRS) are collected at baseline and after eight weeks to measure changes in microbial diversity, inflammation, immune activity, digestive enzyme markers, and intestinal barrier integrity. The study uses objective stool-based laboratory biomarkers alongside validated patient-reported outcome measures to characterize gut and digestive health before and after the intervention. No placebo or control arm is included, so results will reflect changes observed within participants over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• San Francisco Research Institute
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Dr. John Ademola
• Email: jademola@sfinstitute.com
• Phone: 415-845-4638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.