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Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico

NCT04145856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-01-23

No results posted yet for this study

Summary

This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

I31 probiotic

I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)

COMBINATION_PRODUCT

I31 probiotic combined to Alverine/Simethicone

* I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d) * Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d)

OTHER

Placebo

Placebo treatment (maltodextrin), once daily (u.i.d)

Sponsors & Collaborators

  • Hospital Juarez de Mexico

    lead OTHER_GOV

Principal Investigators

  • Nuria Lopez Perez, MD · Hospital Juarez de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2019-05-02
Completion
2019-08-27

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145856 on ClinicalTrials.gov