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

NCT04145856 | Completed Phase 4

• 1 other identifier: HJM 0492/18-R
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotic; Antispasmodic; Rome-IV

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (2)

• Abdominal Pain

  6 weeks

• Diarrhea

  6 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

\- Control arm

Other: Placebo

Probiotic

EXPERIMENTAL

\- Arm with active probiotic alone

Dietary Supplement: I31 probiotic

Probiotic + Antispasmodic/Antifoam

EXPERIMENTAL

\- Arm with active probiotic combined to antispasmodic/antifoam drug

Combination Product: I31 probiotic combined to Alverine/Simethicone

Interventions

I31 probiotic DIETARY_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)

Probiotic

I31 probiotic combined to Alverine/Simethicone COMBINATION_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)

Probiotic + Antispasmodic/Antifoam

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nuria Lopez Perez, MD

  Hospital Juarez de Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Digestive Physiology Lab Head

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: September 3, 2018
• Primary Completion: May 2, 2019
• Study Completion: August 27, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)