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

NCT03952988 | Unknown

• 1 other identifier: UChile-Bifidice-2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC) of hydrogen in the HBT

  Acute effect of the probiotic on hydrogen excretion after lactose ingestion

  Day 15

Secondary Outcomes (20)

• Area under curve (AUC) of hydrogen in the HBT

  Day 43

• Area under curve (AUC) of hydrogen in the HBT

  Day 71

• Fecal microbiota alpha-diversity

  Days 15

• Fecal microbiota alpha-diversity

  Day 43

• Fecal microbiota alpha-diversity

  Day 71

Study Arms (2)

Probiotic

EXPERIMENTAL

Dietary Supplement: Probiotic ice cream

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo ice cream

Interventions

Probiotic ice cream DIETARY_SUPPLEMENT

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

Also known as: Bifidice

Probiotic

Placebo ice cream DIETARY_SUPPLEMENT

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of hypolactasia and lactose intolerance

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Chile: lead

Related Publications (7)

• Marteau P, Pochart P, Flourie B, Pellier P, Santos L, Desjeux JF, Rambaud JC. Effect of chronic ingestion of a fermented dairy product containing Lactobacillus acidophilus and Bifidobacterium bifidum on metabolic activities of the colonic flora in humans. Am J Clin Nutr. 1990 Oct;52(4):685-8. doi: 10.1093/ajcn/52.4.685.

  PMID: 2119557 RESULT

• Pelletier X, Laure-Boussuge S, Donazzolo Y. Hydrogen excretion upon ingestion of dairy products in lactose-intolerant male subjects: importance of the live flora. Eur J Clin Nutr. 2001 Jun;55(6):509-12. doi: 10.1038/sj.ejcn.1601169.

  PMID: 11423928 RESULT

• Jiang T, Mustapha A, Savaiano DA. Improvement of lactose digestion in humans by ingestion of unfermented milk containing Bifidobacterium longum. J Dairy Sci. 1996 May;79(5):750-7. doi: 10.3168/jds.S0022-0302(96)76422-6.

  PMID: 8792277 RESULT

• Almeida CC, Lorena SL, Pavan CR, Akasaka HM, Mesquita MA. Beneficial effects of long-term consumption of a probiotic combination of Lactobacillus casei Shirota and Bifidobacterium breve Yakult may persist after suspension of therapy in lactose-intolerant patients. Nutr Clin Pract. 2012 Apr;27(2):247-51. doi: 10.1177/0884533612440289. Epub 2012 Mar 8.

  PMID: 22402407 RESULT

• Turroni F, Duranti S, Bottacini F, Guglielmetti S, Van Sinderen D, Ventura M. Bifidobacterium bifidum as an example of a specialized human gut commensal. Front Microbiol. 2014 Aug 21;5:437. doi: 10.3389/fmicb.2014.00437. eCollection 2014.

  PMID: 25191315 RESULT

• Gargari G, Taverniti V, Balzaretti S, Ferrario C, Gardana C, Simonetti P, Guglielmetti S. Consumption of a Bifidobacterium bifidum Strain for 4 Weeks Modulates Dominant Intestinal Bacterial Taxa and Fecal Butyrate in Healthy Adults. Appl Environ Microbiol. 2016 Sep 16;82(19):5850-9. doi: 10.1128/AEM.01753-16. Print 2016 Oct 1.

  PMID: 27451450 RESULT

• Hsu CA, Yu RC, Lee SL, Chou CC. Cultural condition affecting the growth and production of beta-galactosidase by Bifidobacterium longum CCRC 15708 in a jar fermenter. Int J Food Microbiol. 2007 May 1;116(1):186-9. doi: 10.1016/j.ijfoodmicro.2006.12.034. Epub 2007 Jan 19.

  PMID: 17320993 RESULT

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Martin Gotteland, PhD

CONTACT

56-2-29786977; mgottela@med.uchile.cl

Pamela Rojas, MD

CONTACT

56-2-29786770; projas@med.uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Lab. of Digestive physiology

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 16, 2019
• Study Start: August 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: January 31, 2020
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share