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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Alberto Yedro
- Numero di telefono: +34647725527
- Email: gestion@galaserviciosclinicos.es
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in Gastrointestinal Symptom Rating Scale score
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change from baseline in Irritable Bowel Syndrome Severity Scoring System score
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sergio Chamorro Benítez, MD, Hospital Parque Vegas Altas, Don Benito (Badajoz)
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AORA-ENZYMAX-DUOBIOTICS-IBS-20
Piano per i dati dei singoli partecipanti (IPD)
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