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

Hospital Juarez de Mexico

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Other: Placebo; Combination Product: I31 probiotic combined to Alverine/Simethicone; Dietary Supplement: I31 probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04145856

HJM 0492/18-R

Details and patient eligibility

About

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

Full 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

Enrollment: 55 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

- Control arm

Treatment:

Other: Placebo

Probiotic

Experimental group

Description:

- Arm with active probiotic alone

Treatment:

Dietary Supplement: I31 probiotic

Probiotic + Antispasmodic/Antifoam

Experimental group

Description:

- Arm with active probiotic combined to antispasmodic/antifoam drug

Treatment:

Combination Product: I31 probiotic combined to Alverine/Simethicone