NCT04164394

Effect of I31 Probiotic on Lactose Intolerance

Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.

Detailed description

People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking dairy products. A deficiency of lactase - an enzyme produced in your small intestine - is usually responsible for lactose intolerance. Many people have low levels of lactase but are able to digest milk products without problems. In lactose intolerance, though, lactase deficiency leads to symptoms after eating dairy foods. I31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose intolerance, it is hypothesized that I31 formula could be beneficial for individuals with lactose intolerance.

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
OTHER	Placebo	Placebo treatment (maltodextrin), once daily (u.i.d)
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)

Timeline

• Start date: 2019-05-13
• Primary completion: 2019-12-10
• Completion: 2019-12-31
• First posted: 2019-11-15
• Last updated: 2020-02-11

Locations

1 site across 1 country: Mexico