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

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00611299
First received: January 28, 2008
Last updated: March 17, 2008
Last verified: December 2002
  Purpose

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 Intervention Phase
Cardiovascular Disease
Constipation
Dietary Supplement: BB-12 and CRL 431
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 71
Study Start Date: April 2003
Estimated Study Completion Date: November 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611299

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00611299     History of Changes
Other Study ID Numbers: BC Vcap 01
Study First Received: January 28, 2008
Last Updated: March 17, 2008
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on August 19, 2014