Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation

NCT00763399 | Completed Phase 4 DMC

• 1 other identifier: 97-0549B
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Diarrhea; Constipation

Keywords

probiotics

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea, number of stool passage, bacterial culture for intestinal or cytokine

  within 4 weeks

Secondary Outcomes (1)

• body weight change, appetite and daily intake, Fecal IgA, lactoferrin and calprotectin levels

  Within first two weeks

Study Arms (1)

97-0549B

EXPERIMENTAL

Dietary Supplement: probiotics (antibiophilus(Lactobacillus casei), bio-three)

Interventions

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

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

97-0549B

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diarrhea
• constipation

You may not qualify if:

• Shock
• Sepsis
• Past history with GI tract surgery
• Immunodeficiency

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Diarrhea; Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chien-Chang Chen, MD

  Pediatric Department, Chang Gung Memorial Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of pediatrics

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: October 1, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

TW (1)