Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis

Inflammatory Response Clinical Trial

Official title:

To Explore the Effect of Intestinal Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856138
• Other study ID #: 201507461B0
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. The aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis.

Description:

Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. According to a World Health Organization report in 2003, the median incidence of diarrhea for all children age under 5 years was 3.2 episodes per child-year, and this number has not changed significantly since 1980s. In Taiwan, the enteric pathogens associated mortality is low, but the social burden and economic costs are substantial because of the high incidence.

Intestinal microflora are able to use the substances consumed in the diet: bacteria can transform complex polysaccharides and monosaccharides in short-chain fatty acids. Short-chain fatty acids are a source of energy for colonocytes and directly affect the storage of lipids and the absorption and metabolism of food, creating the so-called 'second meal effect'.

Qualitative and quantitative alterations of commensal flora may result in various gastrointestinal and extraintestinal diseases. One of the first interactions these bacteria have when interacting with the intestinal epithelial cells lining the GI tact.

The first aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis. The second aim of this study is determining the inflammatory markers (such as fecal TNF-α, interleukin -6, calprotectin, lactoferrin) on the host of childhood gastroenteritis. The investigators try to seek to gain an advanced understanding effect of intestinal microbiota and fecal inflammatory marker in the childhood gastroenteritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Children with or without diarrhea less than three days

Exclusion Criteria:

• diabetes

• chronic liver disease

Related Conditions & MeSH terms

• Clinical Infection
• Communicable Diseases
• Gastroenteritis
• Infection
• Inflammatory Response
• Microbial Colonization
• Probiotics

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal bacteria microbiota	Bacteria count in feces	the day of enrollment
Primary	Fecal bacteria microbiota	Bacteria count in feces	3 days after enrollment
Primary	Fecal bacteria microbiota	Bacteria count in feces	7 days after enrollment
Primary	Fecal bacteria microbiota	Bacteria count in feces	1 month after enrollment