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Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763399
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Chien-Chang Chen, MD, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Duration of diarrhea, number of stool passage, bacterial culture for intestinal or cytokine [ Time Frame: within 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
body weight change, appetite and daily intake, Fecal IgA, lactoferrin and calprotectin levels [ Time Frame: Within first two weeks ]
secondary outcome including body weight change, appetite and daily intake, bloating or abdominal distension, abdominal pain or colic, constipation, fever, and vomiting were also assessed. IgA levels and bacterial culture were performed on homogenized fecal samples. Fecal lactoferrin and calprotectin levels were measured with samples of feces.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation
Official Title  ICMJE Phase 4 Study of Probiotics on Intestinal Bacterial Population and Immune Modulation
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.

Detailed Description

Some clinical parameters were evaluated according to the following: primary outcome (severity of diarrhea), and secondary outcome including body weight change, appetite and daily intake, bloating or abdominal distension, abdominal pain or colic, constipation, fever, and vomiting were also assessed.

Peripheral blood isolated by Lymphoprep, washed twice in normal saline and once in medium, and suspended in medium [RPMI 1640] to a density of 1 x 106/mL. PBMCs will be isolated from blood donor buffy coats by density gradient centrifugation. The concentration of PBMCs will be adjusted to 106 cells per ml in complete medium, and the cells will be transferred to 24-well plates.Cell surface phenotype expression and intracellular staining. Cells will be stained using a panel of monoclonal antibody (MAb) directed against surface antigens expressed by lymphocytes, monocytes and the appropriate species-specific immunoglobulin G isotype controls. Cells will be acquired using an FACScan (Becton Dickinson) and analyzed with Cell Quest software.

To assess the colonization of intestinal bacteria, fecal samples were collected from each patient on day 0 (the day when patients were enrolled), day 3 and day 7 after probiotics or placebo treatment. The fecal specimens were weighed, homogenized, and serially diluted and plated on selective agar for analysis of bacteria. Fecal bacteria count was expressed as log10 CFU/g feces.

Fecal samples were collected during the treatment period. IgA levels were performed on homogenized fecal samples. Total IgA was determined using goat anti-human IgA-HRP conjugate. The reaction was developed with tetramethyl benzidine (TMB; Zymed Labs.) and read at 450 nm. OD values were converted to ng/g feces of total IgA by comparison with a standard curve developed with anti-human IgA.

The stool samples were prepared and analyzed for lactoferrin. A polyclonal antibody specific for lactoferrin has been pre-coated onto a microplate. Lactoferrin in standards and samples is sandwiched by the immobilized antibody and a biotinylated polyclonal antibody specific for lactoferrin, which is recognized by a streptavidin-peroxidase conjugate. Absorbance is read at OD 450 nm. Lactoferrin was expressed as μg/g feces.

The stool samples were prepared and analyzed for calprotectin. The supernatant was collected and frozen at -20°C. The supernatants were thawed and calprotectin was analyzed with the quantitative calprotectin ELISA and read at OD 450 nm. Calprotectin was expressed as μg/g feces.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diarrhea
  • Constipation
Intervention  ICMJE Dietary Supplement: probiotics (antibiophilus(Lactobacillus casei), bio-three)
probiotics (antibiophilus(Lactobacillus casei), bio-three) 4x 10^8CFU/day
Study Arms  ICMJE Experimental: 97-0549B
Intervention: Dietary Supplement: probiotics (antibiophilus(Lactobacillus casei), bio-three)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 29, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diarrhea
  • constipation

Exclusion Criteria:

  • Shock
  • Sepsis
  • Past history with GI tract surgery
  • Immunodeficiency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763399
Other Study ID Numbers  ICMJE 97-0549B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chien-Chang Chen, MD, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chien-Chang Chen, MD Pediatric Department, Chang Gung Memorial Hospital, Taiwan
PRS Account Chang Gung Memorial Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP