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

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ClinicalTrials.gov Identifier: NCT03952988
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Gotteland, 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.


Condition or disease Intervention/treatment Phase
Lactose Intolerance Dietary Supplement: Probiotic ice cream Dietary Supplement: Placebo ice cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Bifidice

Placebo Comparator: Placebo Dietary Supplement: Placebo ice cream
One portion (50g) of an ice-cream without probiotic every day for 4 weeks
Other Name: Placebo




Primary Outcome Measures :
  1. Area under curve (AUC) of hydrogen in the HBT [ Time Frame: Day 15 ]
    Acute effect of the probiotic on hydrogen excretion after lactose ingestion


Secondary Outcome Measures :
  1. Area under curve (AUC) of hydrogen in the HBT [ Time Frame: Day 43 ]
    Chronic effect of the probiotic on hydrogen excretion after lactose ingestion

  2. 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

  3. Fecal microbiota alpha-diversity [ Time Frame: Days 15 ]
    Shannon Index

  4. Fecal microbiota alpha-diversity [ Time Frame: Day 43 ]
    Shannon Index

  5. Fecal microbiota alpha-diversity [ Time Frame: Day 71 ]
    Shannon Index

  6. 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

  7. 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

  8. 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

  9. Fecal counts of B. bifidum 900791 [ Time Frame: Days 15 ]
    B. bifidum 900791 counts in fecal samples

  10. Fecal counts of B. bifidum 900791 [ Time Frame: Days 43 ]
    B. bifidum 900791 counts in fecal samples

  11. Fecal counts of B. bifidum 900791 [ Time Frame: Days 71 ]
    B. bifidum 900791 counts in fecal samples

  12. Fecal beta-galactosidase activity [ Time Frame: Days 15 ]
    Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)

  13. Fecal beta-galactosidase activity [ Time Frame: Days 43 ]
    Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)

  14. Fecal beta-galactosidase activity [ Time Frame: Days 71 ]
    Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)

  15. Fecal short chain fatty acids concentrations [ Time Frame: Days 15 ]
    Determination of short chain fatty acids concentrations in fecal samples

  16. Fecal short chain fatty acids concentrations [ Time Frame: Days 43 ]
    Determination of short chain fatty acids concentrations in fecal samples

  17. Fecal short chain fatty acids concentrations [ Time Frame: Days 71 ]
    Determination of short chain fatty acids concentrations in fecal samples

  18. 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.

  19. 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.

  20. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952988


Contacts
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Contact: Martin Gotteland, PhD 56-2-29786977 mgottela@med.uchile.cl
Contact: Pamela Rojas, MD 56-2-29786770 projas@med.uchile.cl

Sponsors and Collaborators
University of Chile

Publications of Results:

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Responsible Party: Martin Gotteland, Head, Lab. of Digestive physiology, University of Chile
ClinicalTrials.gov Identifier: NCT03952988     History of Changes
Other Study ID Numbers: UChile-Bifidice-2
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases