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

January 21, 2020 updated by: Nuria Pérez López, Hospital Juarez de 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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Cdmx
      • Ciudad de Mexico, Cdmx, Mexico, 07760
        • Hospital Juarez de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
- Control arm
Other: Placebo
Placebo treatment (maltodextrin), once daily (u.i.d)
Experimental: Probiotic
- Arm with active probiotic alone
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)
Experimental: Probiotic + Antispasmodic/Antifoam
- Arm with active probiotic combined to antispasmodic/antifoam drug
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life (QoL)
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Pain
Time Frame: 6 weeks
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.
6 weeks
Diarrhea
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Juarez de Mexico

Investigators

  • Study Director: Nuria Lopez Perez, MD, Hospital Juarez de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

August 27, 2019

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJM 0492/18-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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