Dose-Response Study of Probiotic Bacteria BB-12 and CRL-431 in Healthy Young Adults
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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 |
- 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 |
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 |
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 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 May 21, 2013