Enzymax DuoBiotics for Irritable Bowel Syndrome (ENZYMAX-IBS)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alberto Yedro
- Número de teléfono: +34647725527
- Correo electrónico: gestion@galaserviciosclinicos.es
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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).
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Comparador de placebos: 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.
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Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change from baseline in Irritable Bowel Syndrome Severity Scoring System total score
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sergio Chamorro Benítez, MD, Hospital Parque Vegas Altas, Don Benito (Badajoz)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AORA-ENZYMAX-DUOBIOTICS-IBS-20
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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