Effect of I31 Probiotic on Lactose Intolerance

NCT ID: NCT04164394

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

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)

Group Type: EXPERIMENTAL

I31 Probiotic

Intervention Type: 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)

Interventions

Placebo

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

Intervention Type: OTHER

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nuria Pérez López

Digestive Physiology Lab Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuria Perez Lopez, MD

Role: STUDY_DIRECTOR

Hospital Juarez de Mexico

Locations

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM 0431/18-R

Identifier Type: -

Identifier Source: org_study_id