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

Hospital Juarez de Mexico55 enrolled

Overview

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

Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention. I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in patients with IBS of Caucasian descent. Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and facilitates its elimination from the digestive tract

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

I31 probioticDIETARY_SUPPLEMENT

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)

I31 probiotic combined to Alverine/SimethiconeCOMBINATION_PRODUCT

* 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)

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects attending Hospital Juarez de Mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (IBS-D and IBS-M), according to Rome-IV criteria (Lacy et al. Gastroenterology 2016), providing Informed Consent. Exclusion Criteria: * Unexplained weight loss, blood in feces, anemia. * Use of systemic antibiotics, NSAIDs, antipsychotic or prokinetic medication in the 3 weeks before study initiation. * Pregnant or lactating women. * History of gastrointestinal cancer. * Suspicion of coeliac disease, inflammatory bowel disease (IBD), endometriosis or pelvic inflammatory disease. * History of abdominal surgery within 2 years (3 months if appendectomy or herniorraphy) * BMI below 18 * Known allergy to any of the components in the treatments

Locations (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Disease-specific quality of life (QoL)

Irritable bowel syndrome-specific validated IBSQoL questionnaire (Hahn et al. Aliment Pharmacol Ther 1997). Response is defined as an improvement of 15 or more points in the normalized 0-100 score

Time frame: 6 weeks

Secondary Outcomes

Abdominal Pain

Abdominal Pain Visual Analog Scale, ranging 0 to 10 (i.e. 11-point scale, as recommended by FDA, May 2012 Guidance on Irritable Bowel Syndrome - Clinical Evaluation of Products for Treatment). Response is defined as an improvement of 30% at the end of the intervention compared to baseline.

Time frame: 6 weeks

Diarrhea

Stool consistency as determined with the Bristol scale (Lewis \& Heaton, Scand. J. Gastroenterol 1997). Response is defined as a score equal or below 5 at the end of the intervention.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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