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NCT Number: NCT07033000

A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes and Extracts on Bloating in Adults.

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo

Dietary Supplement with actives

Dietary Supplement

Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger & Fennel Extracts

Primary outcomes

  1. 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

    Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.

Secondary outcomes

  1. To estimate the changes in abdominal circumference as an indicator of distention

    Time frame: From time of enrollement to end of study at Week4

    Standardized tape measurement at the level of the iliac crest or on top of belly button will be used to evaluate changes in abdominal distention at baseline and after the study at Week4.

  2. 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

    Participants will take Visual Analogue Scale (VAS) which is a self-reported assessment of bloating and distention severity using PROMIS's GI gas and bloating questionnaire at baseline and after the study at Week4.

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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