Clinical Research Directory
Browse clinical research sites, groups, and studies.
Enzymax DuoBiotics for Irritable Bowel Syndrome
Sponsor: Gala Servicios Clinicos S.L.
Summary
This randomized, double-blind, placebo-controlled, parallel-group clinical trial will evaluate the efficacy and safety of Enzymax DuoBiotics in adults with irritable bowel syndrome diagnosed according to Rome IV criteria. A total of 120 participants will be randomized in a 1:1 ratio to receive either Enzymax DuoBiotics or placebo once daily for 12 weeks. The primary objective is to assess changes in gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS) and the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). Secondary outcomes include inflammatory biomarkers, irritable bowel syndrome-related quality of life, stool consistency, treatment satisfaction, adherence, and safety. Assessments will be performed at baseline, Week 6, and Week 12.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Enzymax DuoBiotics in Adults With Irritable Bowel Syndrome
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-09-30
Completion Date
2027-09-30
Last Updated
2026-07-21
Healthy Volunteers
No
Interventions
Enzymax DuoBiotics
Participants will receive one capsule of Enzymax DuoBiotics orally once daily for 12 weeks. Each capsule uses a capsule-in-capsule delivery system. The outer capsule, intended for release in the stomach, contains lipase (4,000 FIP), protease 4.5 (3,120 HUT), protease 3.0 (15 SAPU), amylase (2,150 DU), and glucoamylase (14 AGU). The inner capsule, intended for release in the intestine, contains Lactobacillus plantarum (5 × 10⁹ CFU) and fructooligosaccharides (140 mg).
Placebo
Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.