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Completed

NCT Number: NCT00611299

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Human Nutrition

Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BB-12 and CRL 431

Dietary Supplement

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2003
First posted
Feb 8, 2008
Registry last updated
Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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