Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis

NCT ID: NCT05213325

Last Updated: 2022-01-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-12-15

Brief Summary

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Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.

Detailed Description

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Conditions

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Acute Gastroenteritis Acute Diarrhea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Children with acute diarrhea

Evaluation of serum levels of IL-6 and IL-8

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 months to 5 years.
* 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

* 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

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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John Samuel Shaker

resident doctor at pediateric department sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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John s shaker, MBBCH

Role: CONTACT

012057258026

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.

Reference Type BACKGROUND
PMID: 30945960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23899552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29371270 (View on PubMed)

Other Identifiers

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Soh-Med-21-12-07

Identifier Type: -

Identifier Source: org_study_id

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