Enzymax DuoBiotics for Irritable Bowel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGala Servicios Clinicos S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Enzymax DuoBiotics
Dietary supplementParticipants 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
Dietary supplementParticipants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Enzymax DuoBioticsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
The Gastrointestinal Symptom Rating Scale is a 15-item questionnaire used to assess the severity of gastrointestinal symptoms across five symptom domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a 7-point scale ranging from 1, indicating no troublesome symptoms, to 7, indicating very troublesome symptoms. The overall score is calculated as the mean of the item scores and ranges from 1 to 7. Higher scores indicate greater gastrointestinal symptom severity and therefore a worse outcome. Change from baseline will be assessed at Weeks 6 and 12, with the primary comparison performed at Week 12.
Time frame
Baseline, Week 6, and Week 122
Change from baseline in Irritable Bowel Syndrome Severity Scoring System total score
The Irritable Bowel Syndrome Severity Scoring System assesses the severity of irritable bowel syndrome symptoms, including abdominal pain, abdominal distension, satisfaction with bowel habits, and the impact of symptoms on daily life. The total score ranges from 0 to 500. Higher scores indicate greater symptom severity and therefore a worse outcome. Change from baseline will be assessed at Weeks 6 and 12, with the primary comparison performed at Week 12.
Time frame
Baseline, Week 6, and Week 12Locations
Sponsors and contacts
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Gala Servicios Clinicos S.L.
Lead sponsor
University of Extremadura
Collaborator
Source ClinicalTrials.gov
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