Effect of I31 Probiotic on Lactose Intolerance

NCT04164394 | Completed

• 1 other identifier: HJM 0431/18-R
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lactose Intolerance

Keywords

Probiotic; Diarrhea; Abdominal pain; Flatulence

Outcome Measures

Primary Outcomes (1)

• 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

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

Secondary Outcomes (5)

• Abdominal Pain subscore

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

• Vomiting subscore

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

• Intestinal Sounds subscore

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

• Flatulence subscore

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

• Lactose Hydrogen Breath Test (LHBT)

  3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Probiotic

EXPERIMENTAL

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)

Dietary Supplement: I31 Probiotic

Interventions

Placebo OTHER

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

Placebo

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)

Probiotic

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 intestinal perforation
• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Lactose Intolerance; Diarrhea; Abdominal Pain; Flatulence

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Nuria Perez Lopez, MD

  Hospital Juarez de Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Digestive Physiology Lab Head

Model Details: Allocation is 2:1 to probiotic and placebo arms

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 15, 2019
• Study Start: May 13, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)