Dietary Supplement with actives: Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts
Study summary
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Healthy Adults aged 18-65 years
2. Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months
3. Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
4. Ability to provide informed consent and comply with all protocol requirements
Exclusion Criteria:
1. Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
2. Use of antibiotics, laxatives, or probiotics within the past 4 weeks
3. Uncontrolled diabetes mellitus
4. Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
5. Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
6. Excessive alcohol intake (\>14 drinks/week for men, \>7 drinks/week for women)
7. Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics)
8. Pregnant or breastfeeding women
9. Use of systemic corticosteroids or immunosuppressant drugs.
10. History of reaction to the category of product tested
11. Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
12. Employee of CRO or product manufacturer
Primary outcome measure(s)
To determine the impact of BTB on hydrogen and methane production in healthy adults — From time of enrollement to end of study at Week4 Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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