Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis
NCT ID: NCT05213325
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2021-12-15
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
Children with acute diarrhea
Evaluation of serum levels of IL-6 and IL-8
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)
Control
Healthy control children
Evaluation of serum levels of IL-6 and IL-8
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)
Interventions
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Evaluation of serum levels of IL-6 and IL-8
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)
Eligibility Criteria
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Inclusion Criteria
* Acute diarrhea: defined according to WHO criteria as the "passage of loose or watery stools at least three times in a 24 h period", lasts less than 14 days, with or without fever or vomiting, but considering the importance of change in stool consistency rather than frequency, and the usefulness of parental insight in deciding whether children have diarrhea or not.
• Healthy children aged 6 months to 5 years.
Exclusion Criteria
* History of antibiotic therapy in the last 72 hours.
* Acute diarrhea in association with systemic infections
* Malignancy
* Chronic diarrhea
* Autoimmune and autoinflammatory diseases.
* Chronic renal/liver failure
* Diabetes mellitus
Group 2: Controls (Healthy control children)
* Acute diarrhea
* Malnutrition or obesity
* History of antibiotic therapy in the last 72 hours.
* Acute diarrhea in association with systemic infections
* Malignancy
* Chronic diarrhea
* Autoimmune and autoinflammatory diseases.
* Chronic renal/liver failure
* Diabetes mellitus
6 Months
5 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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John Samuel Shaker
resident doctor at pediateric department sohag university hospital
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Ashraf M Radwan, MD, PhD
Role: CONTACT
Facility Contacts
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Osama R ElSherif, professor
Role: primary
References
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Muhsen K, Kassem E, Rubenstein U, Goren S, Ephros M, Shulman LM, Cohen D. No evidence of an increase in the incidence of norovirus gastroenteritis hospitalizations in young children after the introduction of universal rotavirus immunization in Israel. Hum Vaccin Immunother. 2019;15(6):1284-1293. doi: 10.1080/21645515.2019.1599522. Epub 2019 May 3.
Chen SM, Lin CP, Tsai JD, Chao YH, Sheu JN. The significance of serum and fecal levels of interleukin-6 and interleukin-8 in hospitalized children with acute rotavirus and norovirus gastroenteritis. Pediatr Neonatol. 2014 Apr;55(2):120-6. doi: 10.1016/j.pedneo.2013.05.008. Epub 2013 Jul 27.
Hamiel U, Bahat H, Kozer E, Hamiel Y, Ziv-Baran T, Goldman M. Diagnostic markers of acute infections in infants aged 1 week to 3 months: a retrospective cohort study. BMJ Open. 2018 Jan 24;8(1):e018092. doi: 10.1136/bmjopen-2017-018092.
Other Identifiers
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Soh-Med-21-12-07
Identifier Type: -
Identifier Source: org_study_id
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