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Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation

NCT00763399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-07-17

No results posted yet for this study

Summary

The balance between immunogenic and tolerogenic activities in human immune system strongly depends on microflora-induced pro-and anti-inflammatory activities. Probiotics are important components of microflora. The interactions of the different strains of probiotics and the cells of immune system are largely unknown.

There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances.

Fecal immunoglobulin A(IgA), lactoferrin and calprotectin were determined by enzyme-linked immunosorbent assay(ELISA) and compared in different groups. Other clinical symptoms or signs, including fever, vomiting, diarrhea, abdominal pain, bloating abdomen, daily intake and body weight were also assessed.

The first aim of our study is to evaluate the role of probiotics and their preparation products on the restoration of intestinal bacterial population. The second aim of our study is determining the immunomodulating effects or anti-inflammatory effects of probiotics on the host (human being). We try to seek to gain an advanced understanding of probiotics versus intestinal microorganism and host interactions, as well as mucosal immune responses to probiotics in the intestine.

Conditions

Interventions

DIETARY_SUPPLEMENT

probiotics (antibiophilus(Lactobacillus casei), bio-three)

probiotics (antibiophilus(Lactobacillus casei), bio-three) 4x 10\^8CFU/day

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chien-Chang Chen, MD · Pediatric Department, Chang Gung Memorial Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763399 on ClinicalTrials.gov