Enzymax DuoBiotics for Irritable Bowel Syndrome

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.

Inclusion Criteria: * Adults aged 18 to 70 years * Diagnosis of irritable bowel syndrome according to the Rome IV criteria. * Presence of active irritable bowel syndrome symptoms at the time of enrollment. * Ability and willingness to provide written informed consent. * Ability and willingness to comply with the study procedures and the 12-week treatment period. Exclusion Criteria: * Presence of an organic gastrointestinal disease. * Use of antibiotics or probiotics within 1 month before enrollment. * Recent clinically relevant changes in diet. * Severe comorbid medical conditions. * Inability or unwillingness to comply with the study protocol. * Known hypersensitivity to any component of Enzymax DuoBiotics or to dietary supplements of similar composition. * Any other condition that, in the investigator's judgment, may interfere with participation, study treatment, or interpretation of the results.