NCT05367453

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

Nutritional Clinical Trial to Evaluate the Regular Consumption Effect of a Probiotic With High Beta-galactosidase Activity Over Lactose Intolerance Gastrointestinal Symptoms in Patients With Lactose Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Probiotics are defined by Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) as "living microorganisms that, properly administrated, confers a benefit on individual's health". Probiotics definition it's closely related to functional food concept, which encompasses either products or ingredients that are able to exert a positive impact on individual's health beyond their nutritional value. In fact, most of consumers in developed countries, strongly associate probiotics as functional foods. Lactic acid bacteria are the main microorganisms used as a probiotic, being Lactobacillus, Bifidobacterium, Propionibacterium and Streptococcus genus the most applied. Additionally, some Saccharomyces yeast may be used as probiotics. However, a microorganism should present particular characteristic in human gastrointestinal's tract to be considered as a probiotic, following the Joint FAO/WHO Group directions: resistance to gastric and pancreatic secretions; adherence to intestinal epithelium and mucosa; antimicrobial activity against pathogenic bacteria; capability of reducing pathogen adhesion on intestinal epithelium; and present certain enzyme activity. The former bacteria genus fulfill most of the previous characteristics. However, these microorganism survival on gut is quite low (1-15%). For this reason, recent Works are searching for microorganism genus able to survive in a larger extend in gut. Non-pathogenic bacteria of Bacillus genus have spore forming ability in the gastrointestinal tract. Specifically, Bacillus coagulans strain has been subject of new studies. B. coagulans has an optimal growth temperature of 35-50ºC, with pH conditions nearby 6. This microorganism consumes glucose, sucrose, maltose and mannitol while growing to produce lactic acid. In addition, B.coagulans is able to produce some enzymes (depending on the strain) such as alpha and beta-galactosidase, alpha-amylase, lipase and protease. However, the capability of growing in gut depends on time from its consumption (mostly oral) and the spore generation rate. The optimal dose is about 9,52x10e11 UFC, if an standard adult of 70 Kg is assumed. In addition, several studies have proved the B.coagulans ability of forming spores in presence of energy sources such as fructose and lactose. 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 designed 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

Type	Name	Description
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)

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-11-30
• Completion: 2022-02-09
• First posted: 2022-05-10
• Last updated: 2022-05-10

Locations

1 site across 1 country: Spain