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Enzymax DuoBiotics for Irritable Bowel Syndrome (ENZYMAX-IBS)

16. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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 komparator: 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.
Kosttilskud: Placebo
Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Gastrointestinal Symptom Rating Scale score
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gala Servicios Clinicos S.L.

Samarbejdspartnere

University of Extremadura

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

23. juni 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AORA-ENZYMAX-DUOBIOTICS-IBS-20

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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