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

NCT ID: NCT07033000

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2025-09-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dietary Supplement with actives

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

Group Type: ACTIVE_COMPARATOR

Dietary Supplement with actives

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement with actives

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Olly, PBC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MusB Research

New Port Richey, Florida, United States

Countries

United States

Facility Contacts

Hariom Yadav

Role: primary

yadavh@musbresearch.com

240-899-5859

Other Identifiers

ULOLLYBTB2

Identifier Type: -

Identifier Source: org_study_id