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

Olly, PBC

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dietary Supplement with actives

Study type: Interventional

Funder types: Industry

Identifiers

NCT07033000

ULOLLYBTB2

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement with actives

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary Supplement with actives