Enzymax DuoBiotics for Irritable Bowel Syndrome (ENZYMAX-IBS)

July 16, 2026 updated by: Gala Servicios Clinicos S.L.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Enzymax DuoBiotics in adults with irritable bowel syndrome (IBS) diagnosed according to the Rome IV criteria. A total of 120 participants aged 18 to 70 years will be randomized in a 1:1 ratio to receive either Enzymax DuoBiotics or placebo once daily for 12 weeks.

Enzymax DuoBiotics is a dietary supplement formulated using a capsule-in-capsule delivery system. The outer capsule contains the digestive enzymes lipase, protease 4.5, protease 3.0, amylase, and glucoamylase and is intended to be released in the stomach. The inner capsule contains the synbiotic combination of Lactobacillus plantarum and fructooligosaccharides and is intended to be released in the intestine. This formulation is designed to separate the digestive enzymes from the synbiotic components and to support their release at the intended gastrointestinal site.

The primary objective is to evaluate the efficacy of Enzymax DuoBiotics in reducing gastrointestinal symptoms associated with IBS. The primary outcomes will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).

Secondary outcomes will include changes in inflammatory biomarkers, including interleukin-6, interleukin-8, tumor necrosis factor alpha, and C-reactive protein; IBS-related quality of life assessed using the Irritable Bowel Syndrome Quality of Life questionnaire; stool consistency assessed using the Bristol Stool Form Scale; treatment satisfaction; treatment adherence based on capsule count; and safety and tolerability based on the recording of adverse events and assessment of their relationship to the study product.

Assessments will be performed at baseline, Week 6, and Week 12. The Week 6 assessment will be conducted by telephone and will include adherence monitoring and completion of electronic questionnaires. The final assessment at Week 12 will include collection of clinical data and questionnaires, evaluation of treatment adherence, and recording of adverse events. The primary analysis will be conducted according to the intention-to-treat principle and may be complemented by a per-protocol analysis.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enzymax DuoBiotics
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
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 Comparator: Placebo
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
Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Gastrointestinal Symptom Rating Scale score
Time Frame: Baseline, Week 6, and Week 12
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The change in the overall GSRS score from baseline to Week 12 will be compared between the Enzymax DuoBiotics and placebo groups. Higher scores indicate greater gastrointestinal symptom severity; therefore, a reduction in score indicates improvement. An intermediate assessment will also be performed at Week 6. The GSRS is a validated instrument for evaluating gastrointestinal symptoms in clinical studies.
Baseline, Week 6, and Week 12
Change from baseline in Irritable Bowel Syndrome Severity Scoring System score
Time Frame: Baseline, Week 6, and Week 12
Irritable bowel syndrome symptom severity will be assessed using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). The change in total IBS-SSS score from baseline to Week 12 will be compared between the Enzymax DuoBiotics and placebo groups. The total score ranges from 0 to 500, with higher scores indicating greater IBS severity; therefore, a reduction in score indicates improvement. An intermediate assessment will also be performed at Week 6.
Baseline, Week 6, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gala Servicios Clinicos S.L.

Collaborators

University of Extremadura

Investigators

  • Principal Investigator: Sergio Chamorro Benítez, MD, Hospital Parque Vegas Altas, Don Benito (Badajoz)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

June 23, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AORA-ENZYMAX-DUOBIOTICS-IBS-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during the trial will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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