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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2003-11-30

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.

Conditions

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Cardiovascular Disease Constipation

Keywords

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Probiotics Immune response Blood lipids Intestinal microflora Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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BB-12 and CRL 431

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Kim F Michaelsen, Prof dr med

Role: PRINCIPAL_INVESTIGATOR

Michaelsen KF

Locations

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Department of Human Nutrition

Frederiksberg C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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BC Vcap 01

Identifier Type: -

Identifier Source: org_study_id