NCT00611299

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (planned)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cardiovascular Disease
• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BB-12 and CRL 431

Timeline

• Start date: 2003-04-01
• Completion: 2003-11-01
• First posted: 2008-02-08
• Last updated: 2008-03-18

Locations

1 site across 1 country: Denmark