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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
I31 probiotic
I31 probiotic combined to Alverine/Simethicone
Placebo
Sponsored by
Hospital Juarez de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Probiotic, Antispasmodic, Rome-IV

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Juarez de Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Probiotic

Probiotic + Antispasmodic/Antifoam

Arm Description

- Control arm

- Arm with active probiotic alone

- Arm with active probiotic combined to antispasmodic/antifoam drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 29, 2019
Last Updated
January 21, 2020
Sponsor
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04145856
Brief Title
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Juarez de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Probiotic, Antispasmodic, Rome-IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
- Control arm
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
- Arm with active probiotic alone
Arm Title
Probiotic + Antispasmodic/Antifoam
Arm Type
Experimental
Arm Description
- Arm with active probiotic combined to antispasmodic/antifoam drug
Intervention Type
Dietary Supplement
Intervention Name(s)
I31 probiotic
Intervention Description
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)
Intervention Type
Combination Product
Intervention Name(s)
I31 probiotic combined to Alverine/Simethicone
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment (maltodextrin), once daily (u.i.d)
Primary Outcome Measure Information:
Title
Disease-specific quality of life (QoL)
Description
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 Outcome Measure Information:
Title
Abdominal Pain
Description
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
Title
Diarrhea
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Lopez Perez, MD
Organizational Affiliation
Hospital Juarez de Mexico
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Juarez de Mexico
City
Ciudad de Mexico
State/Province
Cdmx
ZIP/Postal Code
07760
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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