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Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance

NCT05367453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-10

No results posted yet for this study

Summary

Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.

Based on the foregoing, the group research has design a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.

Conditions

  • Lactose Intolerance

Interventions

DIETARY_SUPPLEMENT

Tropical juice with probiotics (B.coagulans)

Once a day during all the intervention phase, volunteers with lactose intolerance should allow the spore-forming ability of B. coagulans in order to digest lactase from dairy products through regular consumption of Tropical juice with probiotics (B.coagulans)

OTHER

a Tropical juice with no probiotics

Once a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics

OTHER

lactase tablet

lactase tablet

OTHER

placebo tablet (cornstarch)

placebo tablet (cornstarch)

Sponsors & Collaborators

  • Go Fruselva, S.L.

    collaborator UNKNOWN

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2021-11-30
Completion
2022-02-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367453 on ClinicalTrials.gov