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

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03952988
• Other study ID #: UChile-Bifidice-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2019
• Source: University of Chile
• Contact: Martin Gotteland, PhD
• Phone: 56-2-29786977
• Email: mgottela[@]med.uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

References & Publications (7)

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 — View Citation

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 — View Citation

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. Epub 2007 Jan 19. — View Citation

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. — View Citation

Marteau P, Pochart P, Flourié 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

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