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

May 15, 2019 updated by: Martin Gotteland, University of Chile

Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo ice cream
One portion (50g) of an ice-cream without probiotic every day for 4 weeks
Other Names:
  • Placebo
EXPERIMENTAL: Probiotic
Dietary supplement: Probiotic ice cream
One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every day for 4 weeks
Other Names:
  • Bifidice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve (AUC) of hydrogen in the HBT
Time Frame: Day 15
Acute effect of the probiotic on hydrogen excretion after lactose ingestion
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve (AUC) of hydrogen in the HBT
Time Frame: Day 43
Chronic effect of the probiotic on hydrogen excretion after lactose ingestion
Day 43
Area under curve (AUC) of hydrogen in the HBT
Time Frame: Day 71
Remanent effect of the probiotic on hydrogen excretion after lactose ingestion after one month without probiotic ingestion
Day 71
Fecal microbiota alpha-diversity
Time Frame: Days 15
Shannon Index
Days 15
Fecal microbiota alpha-diversity
Time Frame: Day 43
Shannon Index
Day 43
Fecal microbiota alpha-diversity
Time Frame: Day 71
Shannon Index
Day 71
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time Frame: Day 15
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Day 15
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time Frame: Day 43
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Day 43
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time Frame: Day 71
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Day 71
Fecal counts of B. bifidum 900791
Time Frame: Days 15
B. bifidum 900791 counts in fecal samples
Days 15
Fecal counts of B. bifidum 900791
Time Frame: Days 43
B. bifidum 900791 counts in fecal samples
Days 43
Fecal counts of B. bifidum 900791
Time Frame: Days 71
B. bifidum 900791 counts in fecal samples
Days 71
Fecal beta-galactosidase activity
Time Frame: Days 15
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Days 15
Fecal beta-galactosidase activity
Time Frame: Days 43
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Days 43
Fecal beta-galactosidase activity
Time Frame: Days 71
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Days 71
Fecal short chain fatty acids concentrations
Time Frame: Days 15
Determination of short chain fatty acids concentrations in fecal samples
Days 15
Fecal short chain fatty acids concentrations
Time Frame: Days 43
Determination of short chain fatty acids concentrations in fecal samples
Days 43
Fecal short chain fatty acids concentrations
Time Frame: Days 71
Determination of short chain fatty acids concentrations in fecal samples
Days 71
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time Frame: Days 15
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.
Days 15
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time Frame: Days 43
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.
Days 43
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time Frame: 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.
Days 71

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

November 30, 2019

Study Completion (ANTICIPATED)

January 31, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UChile-Bifidice-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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