- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03856138
Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis
To Explore the Effect of Intestinal Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Children with or without diarrhea less than three days
Exclusion Criteria:
- diabetes
- chronic liver disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
diarrhea with probiotics supplement
The children suffered from diarrhea, gastroenteritis oral probiotics during the clinical course
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diarrhea without probiotics supplement
The children suffered from diarrhea, gastroenteritis no oral probiotics during the clinical course
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healthy control
The children without diarrhea/ gastroenteritis
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fecal bacteria microbiota
Tidsramme: the day of enrollment
|
Bacteria count in feces
|
the day of enrollment
|
Fecal bacteria microbiota
Tidsramme: 3 days after enrollment
|
Bacteria count in feces
|
3 days after enrollment
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Fecal bacteria microbiota
Tidsramme: 7 days after enrollment
|
Bacteria count in feces
|
7 days after enrollment
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Fecal bacteria microbiota
Tidsramme: 1 month after enrollment
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Bacteria count in feces
|
1 month after enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Chien-Chang Chen, MD, Chang Gung Memorial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201507461B0
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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