Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

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.
    

Intervention name(s): Tropical juice with probiotics (B.coagulans); a Tropical juice with no probiotics; lactase tablet; placebo tablet (cornstarch)
Intervention type(s): Dietary Supplement; Other; Other; Other
Intervention description(s): 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); Once a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics; lactase tablet; placebo tablet (cornstarch)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment