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Gastrointestinal SymptomsNCT07421596

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

A study testing PhytoPower 1 and PhytoPower 2 in people with Gastrointestinal Symptoms and Digestive Health, run by SF Research Institute, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
PhytoPower 1 and PhytoPower 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
5 Feb 2026to 21 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. John Ademola contact

415-845-4638

jademola@sfinstitute.com

United States1 site, 1 recruiting
  • San Francisco Research Institute

    San Francisco, California, 94132

    Khaleeq Rehman, 415-690-9641, khaleeqr.sfinstitute@gmail.com

    Recruiting

Other trials in United States

About this study

Official title: An Eight-week Clinical Study for the Measurement of Gut and Digestive Health Parameters Before and After the Use of a Dietary Supplement System

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.

Read more

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.

Read the 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 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.

Being tested
PhytoPower 1 and PhytoPower 2
Keywords
Stool biomarkers, Probiotics, Subjective digestive health, Gut Zoomer stool test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhytoPower 1 and PhytoPower 2Dietary supplement

    The intervention consists of a dietary supplement system comprising two study products, PhytoPower 1 and PhytoPower 2. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 together in 16 fl. oz. of water and consume the prepared mixture once daily in the morning, with or without food, for a total duration of 8 weeks (56 days). Study products will be dispensed at the Baseline Visit and again at the Week 4 Visit in quantities sufficient to last until the next scheduled visit.

Study groups in NCT07421596
Study groupRoleWhat they receive
Dietary Supplement GroupExperimentalParticipants in this single-arm study will receive a dietary supplement system consisting of two study products, PhytoPower 1 and PhytoPower 2, administered once daily for 8 weeks. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 into 16 fl. oz. of water and consume the prepared mixture every morning, with or without food. The study will evaluate changes in gut and digestive health parameters using stool-based biomarkers and validated gastrointestinal symptom questionnaires over the study period.
Receives: Dietary Supplement: PhytoPower 1 and PhytoPower 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Gut Microbial Diversity

    Mean change from baseline to Week 8 in gut microbial diversity assessed using stool-based analysis as part of the Gut Zoomer® test.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  2. Mean Change in Stool Calprotectin Concentration from Baseline to Week 8

    Mean change from baseline to Week 8 in stool calprotectin concentration, a marker of intestinal inflammation, measured using the Gut Zoomer® test.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  3. Mean Change in Stool Beta-Defensin 2 Concentration from Baseline to Week 8

    Mean change from baseline to Week 8 in stool beta-defensin 2 concentration, an intestinal immune marker, measured using the Gut Zoomer® test.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  4. Mean Change in Stool Secretory Immunoglobulin A (sIgA) Concentration from Baseline to Week 8

    Mean change from baseline to Week 8 in stool secretory Immunoglobulin A (sIgA) concentration, an intestinal immune marker, measured using the Gut Zoomer® test.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  5. Change in Digestive Function Biomarkers

    Mean change from baseline to Week 8 in digestive health biomarkers (short-chain fatty acids) assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  6. Mean Change in Stool Bile Acid Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool bile acid concentration assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  7. Mean Change in Stool Malabsorption Marker Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool-based markers of malabsorption assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  8. Mean Change in Stool Lipopolysaccharide (LPS) Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool lipopolysaccharide (LPS) concentration assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  9. Mean Change in Stool Zonulin Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool zonulin concentration assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  10. Mean Change in Stool Tissue Transglutaminase (tTG) Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool tissue transglutaminase (tTG) concentration assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

  11. Mean Change in Stool Anti-Gliadin Antibody Concentration From Baseline to Week 8

    Mean change from baseline to Week 8 in stool anti-gliadin antibody concentration assessed using stool-based analysis.

    Measured: Baseline (Day 1) to Week 8 (End of Study)

Secondary outcomes (3)
  1. Change in Gastrointestinal Symptom Rating Scale (GSRS) Score

    To evaluate changes in gastrointestinal symptoms, including abdominal pain, reflux, indigestion, bloating, constipation, and diarrhea, as measured by the validated Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a patient-reported questionnaire using a 7-point Likert scale, with higher scores indicating greater symptom severity.

    Measured: Baseline, Week 2, Week 4, Week 6, and Week 8

  2. Change in Subjective Digestive Health and Well-Being Questionnaire Scores

    To assess participant-reported changes in digestive comfort, overall well-being, energy levels, mood, skin health, mental clarity, product tolerability, and user experience using a custom Subjective Digestive Health and Well-Being Questionnaire administered throughout the study.

    Measured: Baseline, Week 2, Week 4, Week 6, and Week 8

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Incidence, severity, and relationship to study product of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported during the 8-week study period.

    Measured: Baseline, Week 2, Week 4, Week 6, and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start5 Feb 2026 (estimated)
  3. Primary completion6 Apr 2026 (estimated)
  4. Study completion21 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model 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 8-week period. All enrolled participants will receive the same study intervention and will be followed according to a predefined visit schedule.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421596
Sponsor's protocol ID
LV-GUT-CT-01-26
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PhytoPower 1 and PhytoPower 2 in people with Gastrointestinal Symptoms and Digestive Health, run by SF Research Institute, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gut Microbial Diversity (time frame: Baseline (Day 1) to Week 8 (End of Study)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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