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Completed

NCT Number: NCT04145856

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

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Juarez de Mexico

Mexico City, 07760, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Placebo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2019
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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