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NCT07421596 · SF Research Institute, Inc.

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

What this study is about

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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

  • San Francisco, California

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations

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1 of 50 participants interested
2% interest

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A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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RECRUITING

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California

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Gastrointestinal Symptoms Treatment in San Francisco?

Join others in California exploring innovative treatment options through clinical research

Gastrointestinal Symptoms Treatment Options in San Francisco, California

If you're searching for Gastrointestinal Symptoms treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Gastrointestinal Symptoms. All study-related care is provided at no cost to participants.

Local Sites
1 locations in California
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Gastrointestinal Symptoms?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Gastrointestinal Symptoms

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Gastrointestinal Symptoms Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07421596. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.