A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes and Extracts on Bloating in Adults.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Dietary Supplement with actives.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes andDandelion, Ginger & Fennel Extracts on Bloating in Adults.
Overview
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.
Interventions
- Dietary supplement Placebo
Placebo - Dietary supplement Dietary Supplement with actives
Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts
Primary outcome measures
- To determine the impact of BTB on hydrogen and methane production in healthy adults [Time frame: From time of enrollement to end of study at Week4]
Secondary outcome measures (2)
- To estimate the changes in abdominal circumference as an indicator of distention [Time frame: From time of enrollement to end of study at Week4]
- To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence. [Time frame: From time of enrollement to end of study at Week4]
Eligibility criteria
Inclusion criteria
- Healthy Adults aged 18-65 years
- 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
- Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
- Ability to provide informed consent and comply with all protocol requirements
Exclusion criteria
- Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
- Use of antibiotics, laxatives, or probiotics within the past 4 weeks
- Uncontrolled diabetes mellitus
- Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
- Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
- Excessive alcohol intake (>14 drinks/week for men, >7 drinks/week for women)
- Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics)
- Pregnant or breastfeeding women
- Use of systemic corticosteroids or immunosuppressant drugs.
- History of reaction to the category of product tested
- Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- Employee of CRO or product manufacturer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MusB Research — New Port Richey
Identifiers
NCT: NCT07033000 · ULOLLYBTB2