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

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ClinicalTrials.gov Identifier: NCT00611299
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : March 18, 2008
Information provided by:
University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Constipation Dietary Supplement: BB-12 and CRL 431 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2003
Estimated Study Completion Date : November 2003

Primary Outcome Measures :
  1. Modulation of the immune system
  2. Influence on blood lipids
  3. Bioavailibility of BB-12 and CRL-341
  4. Overall tolerance
  5. Effect on the composition of the gut microflora

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611299

Department of Human Nutrition
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Principal Investigator: Kim F Michaelsen, Prof dr med Michaelsen KF

Additional Information:
ClinicalTrials.gov Identifier: NCT00611299     History of Changes
Other Study ID Numbers: BC Vcap 01
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: December 2002

Keywords provided by University of Copenhagen:
Immune response
Blood lipids
Intestinal microflora

Additional relevant MeSH terms:
Cardiovascular Diseases
Signs and Symptoms, Digestive
Signs and Symptoms