Dose-Response Study of Probiotic Bacteria BB-12 and CRL-431 in Healthy Young Adults

Cardiovascular Disease Clinical Trial

Official title:

Dose-Response Study of Probiotic Bacteria Bifidobacterium Animalis Subsp. Lactis BB-12 and Lactobacillus Paracasei Subsp. Paracasei CRL-341 in Healthy Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611299
• Other study ID #: BC Vcap 01
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2008
• Last updated: March 17, 2008
• Start date: April 2003
• Est. completion date: November 2003

Study information

• Verified date: December 2002
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to investigate the dose-response effect of increasing doses of Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.

Description:

The study included seventy-one healthy young vounteers, and was designed as a double-blind placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and 2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects each, who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a mixture of BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3 times. Diary reporting bowel habits and weel being was kept for all 7 weeks.

There are very few articles concerning the issue dose-response effect of probiotics.The aim of the study was to investigate the dose-response effect of increasing concentrations of probiotics on the immune response, blood lipids, composition of the gut microflora, recovery from feces and the overall tolerance.

The hypothesis was that the increasing dose would influence the immunresponse (eg incresae phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in increasing concentrations in feces, would change the intestinal microfloraprofile and would be well tolerated even in high doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy young individuals

Exclusion Criteria:

• GI-disease

• Colosomi

• Pregnant or lactating women

• Allergy

• Individuals receiving the following medicine: antacid, antibiotics, steroids, medicine with influence the intestinal function.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Constipation

Intervention

Dietary Supplement:
• BB-12 and CRL 431

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulation of the immune system
Primary	Influence on blood lipids
Primary	Bioavailibility of BB-12 and CRL-341
Primary	Overall tolerance
Primary	Effect on the composition of the gut microflora