IL6&8 in Malnourished Children With Acute Diarrhea

NCT05183789 | Unknown

• 1 other identifier: IL6&8
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. However, there have been no previous studies on the levels of IL-6 and IL-8 in malnourished children with acute diarrhea. This study aims to evaluate serum levels of interleukins 6 and 8 in malnourished children with acute diarrhea.

Conditions

Acute Diarrhea; Severe Acute Malnutrition; Acute Gastroenteritis

Keywords

Children; Acute diarrhea; Severe acute malnutrition; Interleukins; Cytokines

Outcome Measures

Primary Outcomes (2)

• Serum level of Interleukin 6

  Difference in serum level of interleukin 6 between cases and control groups

  Within the first 3 days of acute diarrhea

• Serum level of Interleukin 8

  Difference in serum level of interleukin 8 between cases and control groups

  Within the first 3 days of acute diarrhea

Study Arms (2)

Cases

Malnourished children with acute diarrhea

Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

Control

Non-malnourished children with acute diarrhea

Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

Interventions

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

Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits).

Cases; Control

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children presented to the Pediatric Department and Outpatient Clinic at Sohag University Hospital

You may qualify if:

• Age: 6 months to 5 years.
• Severe acute malnutrition. Infants and children who are 6-59 months of age and have a mid-upper arm circumference \< 115 mm or a weight for height/length \<-3 Z-score of the WHO growth standards or have bilateral edema.
• 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.

You may not qualify if:

• 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: Control (Non-malnourished children with acute diarrhea)
• Healthy children aged 6 months to 5 years.
• Acute diarrhea
• Malnutrition or obesity
• History of antibiotic therapy in the last 72 hours.
• Acute diarrhea in association with systemic infections
• Malignancy
• Chronic diarrhea

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 82524, Egypt

RECRUITING

Related Publications (8)

• Zaki MES, Alsayed MAL, Shrief R. Study of the diagnostic value of interleukin-6 and interleukin-8 in children with acute gastroenteritis. Germs. 2020 Mar 2;10(1):27-33. doi: 10.18683/germs.2020.1182. eCollection 2020 Mar.

  PMID: 32274357 BACKGROUND

• Rankin JA. Biological mediators of acute inflammation. AACN Clin Issues. 2004 Jan-Mar;15(1):3-17. doi: 10.1097/00044067-200401000-00002.

  PMID: 14767362 BACKGROUND

• Svanborg C, Godaly G, Hedlund M. Cytokine responses during mucosal infections: role in disease pathogenesis and host defence. Curr Opin Microbiol. 1999 Feb;2(1):99-105. doi: 10.1016/s1369-5274(99)80017-4.

  PMID: 10047563 BACKGROUND

• 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.

  PMID: 23899552 BACKGROUND

• Ibrahim MK, Zambruni M, Melby CL, Melby PC. Impact of Childhood Malnutrition on Host Defense and Infection. Clin Microbiol Rev. 2017 Oct;30(4):919-971. doi: 10.1128/CMR.00119-16.

  PMID: 28768707 BACKGROUND

• Marginean CO, Man L, Pitea AM, Man A, Marginean CL, Cotoi OS. The assessment between IL-6 and IL-8 and anthropometric status in malnourished children. Rom J Morphol Embryol. 2013;54(4):935-8.

  PMID: 24398988 BACKGROUND

• Dulger H, Arik M, Sekeroglu MR, Tarakcioglu M, Noyan T, Cesur Y, Balahoroglu R. Pro-inflammatory cytokines in Turkish children with protein-energy malnutrition. Mediators Inflamm. 2002 Dec;11(6):363-5. doi: 10.1080/0962935021000051566.

  PMID: 12581501 BACKGROUND

• Malave I, Vethencourt MA, Pirela M, Cordero R. Serum levels of thyroxine-binding prealbumin, C-reactive protein and interleukin-6 in protein-energy undernourished children and normal controls without or with associated clinical infections. J Trop Pediatr. 1998 Oct;44(5):256-62. doi: 10.1093/tropej/44.5.256.

  PMID: 9819485 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Abdelrahim A Sadek, MD, PhD

  Faculty of Medicine, Sohag University

  STUDY CHAIR

Central Study Contacts

Motaz Hassan, MBBCH

CONTACT

00201023286623; motaz011193@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately after publication
• Access Criteria: Researchers working on relevant field

Locations

EG (1)