NCT04145856

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

Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-09-03
• Primary completion: 2019-05-02
• Completion: 2019-08-27
• First posted: 2019-10-31
• Last updated: 2020-01-23

Locations

1 site across 1 country: Mexico