Effect of B.Bifidum 900791 Intake in Adult With Hypolactasia and Lactose Intolerance
- Conditions
- Lactose Intolerance
- Interventions
- Dietary Supplement: Probiotic ice creamDietary Supplement: Placebo ice cream
- Registration Number
- NCT03952988
- Lead Sponsor
- University of Chile
- Brief Summary
Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins.
In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics.
Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Diagnosis of hypolactasia and lactose intolerance
- Diarrhea
- Previous gastrointestinal pathologies
- Current or recent intake of antibiotics, anti-inflammatory drugs, laxatives or drugs interfering with intestinal transit
- Alterations of intestinal anatomy or function
- Pregnancy
- Chronic diseases of different etiologies (auto-immune, inflammatory, tumor, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Probiotic ice cream - Placebo Placebo ice cream -
- Primary Outcome Measures
Name Time Method Area under curve (AUC) of hydrogen in the HBT Day 15 Acute effect of the probiotic on hydrogen excretion after lactose ingestion
- Secondary Outcome Measures
Name Time Method Area under curve (AUC) of hydrogen in the HBT Day 71 Remanent effect of the probiotic on hydrogen excretion after lactose ingestion after one month without probiotic ingestion
Fecal microbiota alpha-diversity Day 71 Shannon Index
Relative abundancies of the bacterial taxa forming the the fecal microbiota Day 71 Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Fecal counts of B. bifidum 900791 Days 71 B. bifidum 900791 counts in fecal samples
Fecal beta-galactosidase activity Days 71 Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Fecal short chain fatty acids concentrations Days 71 Determination of short chain fatty acids concentrations in fecal samples
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT Days 71 Determination of gastrointestinal symptoms (bloating, abdominal distention, abdominal pain, borborygms and flatulence) using a previously validated questionnaire on a scale of 0 (none), 1 (mild), 2 (moderate), 3 (severe). We will define clinically relevant ymptoms as a composite score of 3 or more during the HBT.