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

Launched by OLLY, PBC · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a daily supplement made from digestive enzymes and plant extracts can help reduce bloating in adults who experience this uncomfortable feeling at least once a week. Bloating means feeling full or swollen in the belly, which can be bothersome and affect daily life. The study aims to see if this supplement can improve symptoms and quality of life compared to a placebo, which is a harmless pill without active ingredients.

Adults between 18 and 65 years old who are generally healthy but have had bloating or belly swelling regularly for the past six months may be able to join. Participants will need to avoid probiotics, antibiotics, or other supplements during the study unless their doctor says it’s okay. If they join, they will take the supplement daily, keep a daily record of their symptoms, and visit the clinic twice for tests that measure gases in the breath and belly size. They will also complete simple questionnaires about their symptoms and how bloating affects their quality of life. The study is not yet recruiting, and certain people, such as those with serious digestive diseases, recent antibiotic use, or who are pregnant, won’t be eligible. This study hopes to find a safe and natural way to help people who often feel bloated.

Gender

ALL

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