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OpenTrials
Completed

NCT Number: NCT03856138

Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis

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.

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with or without diarrhea less than three days

Exclusion criteria

  • diabetes
  • chronic liver disease

Treatment and study plan

Primary outcomes

  1. Fecal bacteria microbiota

    Time frame: the day of enrollment

    Bacteria count in feces

  2. Fecal bacteria microbiota

    Time frame: 3 days after enrollment

    Bacteria count in feces

  3. Fecal bacteria microbiota

    Time frame: 7 days after enrollment

    Bacteria count in feces

  4. Fecal bacteria microbiota

    Time frame: 1 month after enrollment

    Bacteria count in feces

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2019
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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