Phase
Condition
Non-ulcer Dyspepsia (Nud)
Treatment
PhytoPower 1 and PhytoPower 2
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 Americanrequired) at the time of screening.
Willing and able to provide written informed consent before participation in anystudy-related procedures.
Willing and able to comply with all study procedures, including clinic visits,completion of questionnaires, and stool sample collection at predetermined timepoints.
Willing to collect and provide stool samples, either in-clinic or at home asinstructed.
Willing to abstain from alcohol consumption (including beer, wine, and spirits)for the duration of the study.
Proficient in written and spoken English. 7. Willing to provide a valid emailaddress and mobile phone number and able to complete electronic forms andquestionnaires using a smartphone.
Able and willing to travel to the Research Institute for in-clinic visits andstool sample collection as scheduled.
No known food allergies, based on subject self-report. 10. Willing to maintainusual diet and lifestyle habits, except as required by the study protocol.
Subjects with self-reported gastrointestinal symptoms, defined as a baselineGastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).
Exclusion
Exclusion Criteria:
- Known allergy or hypersensitivity to any ingredient(s) of the study product orother herbal products.
- Presence or history of any medical condition that may interfere with studyparticipation 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 studyperiod, based on subject self-report.
- Having a pregnant partner or a partner who is planning to become pregnantduring the study period and is unwilling or unable to use an acceptable methodof contraception.
- History of any cancer within the past 5 years. 6. Active or occasionalsmoking. 7. Current use of probiotics, unless willing to discontinue use atleast 4 weeks prior to study enrollment.
- History of weight loss surgery or any type of bowel surgery, includingresection or colectomy.
- Any active infection within the past 3 months requiring antibiotics,antiviral medication, or hospitalization.
- Use of immunosuppressive medications within the past 12 months, includingsystemic corticosteroids or biologic agents.
- History of seizure disorder or use of seizure medication within the past 4weeks.
- History of HIV infection or solid organ transplantation. 13. Use ofmedications for chronic gastrointestinal or digestive conditions, including butnot 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 ofhospitalized diverticulitis 14. Any other condition that, in the opinion of thePrincipal Investigator, would make the subject unsuitable for participation orcompromise subject safety or study integrity.
Study Design
Study Description
Connect with a study center
San Francisco Research Institute
San Francisco 5391959, California 5332921 94132
United StatesActive - Recruiting

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