Enzymax DuoBiotics for Irritable Bowel Syndrome

NCT07716852 | Not Yet Recruiting

• 1 other identifier: AORA-ENZYMAX-DUOBIOTICS-IBS-20
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome (IBS)

Keywords

Irritable bowel syndrome; IBS; Enzymax DuoBiotics; Dietary supplement; Synbiotic; Lactobacillus plantarum; Fructooligosaccharides; Digestive enzymes; Gastrointestinal symptoms; Gut microbiota

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 6, and Week 12

• 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.

  Baseline, Week 6, and Week 12

Study Arms (2)

Enzymax DuoBiotics

EXPERIMENTAL

Participants assigned to this arm will receive one capsule of Enzymax DuoBiotics orally once daily for 12 weeks. Enzymax DuoBiotics contains digestive enzymes, Lactobacillus plantarum, and fructooligosaccharides in a capsule-in-capsule delivery system.

Dietary Supplement: Enzymax DuoBiotics

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive one placebo capsule orally once daily for 12 weeks. The placebo will be administered according to the same dosing schedule as Enzymax DuoBiotics.

Dietary Supplement: Placebo

Interventions

Enzymax DuoBiotics DIETARY_SUPPLEMENT

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).

Enzymax DuoBiotics

Placebo DIETARY_SUPPLEMENT

Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gala Servicios Clinicos S.L.: lead
• University of Extremadura: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sergio Chamorro Benítez, MD

  Hospital Parque Vegas Altas, Don Benito (Badajoz)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Yedro

CONTACT

+34647725527; gestion@galaserviciosclinicos.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will remain unaware of treatment allocation throughout the 12-week study period. The active dietary supplement and placebo will be provided in matching coded packaging to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups. The experimental group will receive Enzymax DuoBiotics once daily for 12 weeks, while the control group will receive a matching placebo once daily for the same period. Participants will remain in their assigned group throughout the study. Efficacy, safety, treatment adherence, and patient-reported outcomes will be assessed at baseline, Week 6, and Week 12.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share