Irritable Bowel SyndromeENZYMAX-IBSNCT07716852
Enzymax DuoBiotics for Irritable Bowel Syndrome
A study testing Enzymax DuoBiotics in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome (IBS), run by Gala Servicios Clinicos S.L..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS)
- What is being tested?
- Enzymax DuoBiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Enzymax DuoBiotics, Placebo
- Keywords
- Irritable bowel syndrome, IBS, Enzymax DuoBiotics, Dietary supplement, Synbiotic, Lactobacillus plantarum, Fructooligosaccharides, Digestive enzymes, Gastrointestinal symptoms, Gut microbiota
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzymax DuoBioticsDietary 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).
PlaceboDietary supplement
Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion23 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gala Servicios Clinicos S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Extremadura
- Responsible party
- Sponsor
- Investigators
- Sergio Chamorro Benítez, MD, Principal investigator, Hospital Parque Vegas Altas, Don Benito (Badajoz)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716852
- Sponsor's protocol ID
- AORA-ENZYMAX-DUOBIOTICS-IBS-20
- Acronym
- ENZYMAX-IBS
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the trial will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07716852
- Acronym / sponsor ID
- ENZYMAX-IBS / AORA-ENZYMAX-DUOBIOTICS-IBS-20
- Keywords
- Irritable bowel syndrome, IBS, Enzymax DuoBiotics, Dietary supplement, Synbiotic, Lactobacillus plantarum, Fructooligosaccharides, Digestive enzymes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gala Servicios Clinicos S.L.University, hospital or other
- Collaborators
- University of Extremadura
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enzymax DuoBiotics | Experimental | Dietary Supplement: Enzymax DuoBioticsParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzymax DuoBioticsParticipants 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). | Dietary supplement | Enzymax DuoBiotics |
| PlaceboParticipants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement. | Dietary supplement | Placebo |
Primary outcome
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Time frame: Baseline, Week 6, and Week 12
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.
Change from baseline in Irritable Bowel Syndrome Severity Scoring System total score
Time frame: Baseline, Week 6, and Week 12
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during the trial will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Chamorro Benítez, MD principal investigator
Hospital Parque Vegas Altas, Don Benito (Badajoz)
Questions about this trial
What is this clinical trial studying?
A study testing Enzymax DuoBiotics in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome (IBS), run by Gala Servicios Clinicos S.L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Yedro (+34647725527, gestion@galaserviciosclinicos.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Gastrointestinal Symptom Rating Scale overall score (time frame: Baseline, Week 6, and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.