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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease, Constipation

Intervention / Treatment
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* Dietary Supplement: BB-12 and CRL 431


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: BB-12 and CRL 431|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation of the immune system |  |  | 
| Influence on blood lipids |  |  | 
| Bioavailibility of BB-12 and CRL-341 |  |  | 
| Overall tolerance |  |  | 
| Effect on the composition of the gut microflora |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Immune response, Blood lipids, Intestinal microflora, Tolerance