Effect of I31 Probiotic on Lactose Intolerance

Hospital Juarez de Mexico48 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lactose Intolerance

Interventions

PlaceboOTHER

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

I31 ProbioticDIETARY_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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent. Exclusion Criteria: * More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if \>10ppm persisted, patient was excluded. * BMI below 18 or above 40 * Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study * Subjects with congenital lactase deficiency * Pregnant or lactating women * Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis * History of gastrointestinal surgery in the 6 months prior to inclusion * History of intestinal perforation * History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion * Substance abuse * Untreated thyroid disorder * Cancer * Other severe diseases that in the doctor's opinion could interfere with the study * Known allergy to any of the components in the treatments

Locations (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Overall Symptoms Score

Total score of the "Symptoms Questionnaire for Lactose Malabsorption Screening" (Casellas et al. Dig Dis Sci 2009; 54:1059-65). Score ranges 0 to 50, where 50 represents maximum symptoms severity