Not Yet RecruitingNot Applicable

Enzymax DuoBiotics for Irritable Bowel Syndrome

120 participantsStarted 2026-09-30

Plain-language summary

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits in the absence of detectable structural abnormalities. Its pathophysiology is multifactorial and may involve alterations in the intestinal microbiota, impaired epithelial barrier function, low-grade immune activation, and disturbances in the digestion and fermentation of dietary nutrients. Enzymax DuoBiotics combines digestive enzymes with a synbiotic formulation in a capsule-in-capsule delivery system. The outer capsule contains digestive enzymes intended for release in the stomach, whereas the inner capsule contains Lactobacillus plantarum and fructooligosaccharides intended for release in the intestine. This formulation is designed to separate the enzymatic and synbiotic components and support their delivery to the intended gastrointestinal sites. The combined approach is intended to support macronutrient digestion while modulating the intestinal microbial environment. This randomized, double-blind, placebo-controlled, parallel-group study will compare once-daily Enzymax DuoBiotics with placebo over a 12-week treatment period in adults with IBS. Participants will be allocated in a 1:1 ratio, and treatment effects over time will be evaluated using assessments performed during the treatment period. The primary statistical analysis will use linear mixed-effects models including treatment group, time, and the treatment group-by-time interaction. The primary analysis will follow the intention-to-treat principle and may be supplemented by a per-protocol analysis.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Gastrointestinal Symptom Rating Scale overall score

Timeframe: Baseline, Week 6, and Week 12

Change from baseline in Irritable Bowel Syndrome Severity Scoring System total score

Timeframe: Baseline, Week 6, and Week 12

Trial details

NCT IDNCT07716852

SponsorGala Servicios Clinicos S.L.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-23

Contact for this trial

Alberto Yedro

+34647725527 gestion@galaserviciosclinicos.es

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials