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

NCT07033000 | Not Yet Recruiting

• 1 other identifier: ULOLLYBTB2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• To determine the impact of BTB on hydrogen and methane production in healthy adults

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

  From time of enrollement to end of study at Week4

Secondary Outcomes (2)

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

  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.

  From time of enrollement to end of study at Week4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.

Dietary Supplement: Placebo

Dietary Supplement with actives

ACTIVE COMPARATOR

Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.

Dietary Supplement: Dietary Supplement with actives

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Dietary Supplement with actives DIETARY_SUPPLEMENT

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

Dietary Supplement with actives

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

MusB Research

New Port Richey, Florida, 34653, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 14, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 15, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)