Effect of B.Bifidum 900791 Intake in Adult With Hypolactasia and Lactose Intolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lactose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At Day 1, hypolactasic subjects will perform a Hydrogen Breath Test (HBT) with a placebo ice-cream with 20g lactose (Negative Control). A second HBT will be carried at Day-8 with the same product + an exogenous lactase (Positive control). A 3° HBT will be carried out at Day 15 with the probiotic ice cream with 20g lactose to determine the acute effect of the probiotic. Posteriorly, the subjects will be randomly assigned in one of 2 groups to consume an ice-cream/d, with or without the probiotic, for 4 weeks. At Day-43, they will carry out a 4° HBT with ice cream with 20g lactose and without probiotic (Evaluation of the chronic effect). At Day 71, after 4 weeks washout period, a 5° HBT will be carried out with the ice cream with lactose and without probiotic, to evaluate the remanence of the effect. A fresh stool will be obtained at days 15, 43 and 71 to determine the presence of the probiotic, microbiota composition, ß-galactosidase activity and short chain fatty acid concentrations.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic

Group Type EXPERIMENTAL

Probiotic ice cream

Intervention Type DIETARY_SUPPLEMENT

One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (\>10(exp7)/g) every day for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo ice cream

Intervention Type DIETARY_SUPPLEMENT

One portion (50g) of an ice-cream without probiotic every day for 4 weeks

Interventions

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Probiotic ice cream

One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (\>10(exp7)/g) every day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo ice cream

One portion (50g) of an ice-cream without probiotic every day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bifidice Placebo

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of hypolactasia and lactose intolerance

Exclusion Criteria

* 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.).

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes