IL6&8 in Malnourished Children With Acute Diarrhea

September 17, 2022 updated by: Motaz Mohamed Hassan, Sohag University

Serum Levels of Interleukins 6 and 8 in Malnourished Children With Acute Diarrhea

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute gastroenteritis remains a common health problem among children worldwide with significant morbidity, mortality, and economic burden. Diarrheal diseases account for more than half-million deaths of children under 5 years old every year, most of which take place in low- and middle-income countries (LMICs). Moreover, diarrheal diseases are a leading cause of emergency visits and hospitalization. According to the WHO, acute diarrhea is classified into acute watery diarrhea, acute bloody diarrhea (dysentery), persistent diarrhea, and diarrhea with severe malnutrition. Acute watery diarrhea is the most common category in both high and LMICs. Viral infections (e.g., rotavirus, norovirus, adenovirus) are the leading causes of acute watery diarrhea in children (up to 90% of cases), while bacteria (e.g., shigella, salmonella, Campylobacter, enterotoxigenic E. coli) and parasites (e.g., Cryptosporidium, Giardia, and E. histolytica) account for the remainder of cases.

Cytokines can be used as markers of acute infections, including acute gastroenteritis. Interleukin-6 (IL-6) is produced by lymphoid and non-lymphoid cells and plays important role in regulation of immunity, acute-phase response, and hematopoiesis; IL-6 has a well-known role in the defense mechanism in acute gastroenteritis. Interleukin-8 (IL-8) functions in chemotaxis of inflammatory cells, such as neutrophils and lymphocytes, to the site of inflammation, Both IL-6 and IL-8 are critical for immunity against mucosal infections; they are released from the epithelial cells of the gastrointestinal tract to mount its inflammatory responses to infectious agents at local and systemic levels.

Some studies investigated the role of IL-6 and IL-8 as biomarkers for acute diarrhea in children. Results showed significantly increased serum levels of IL-6 and IL-8 in children with acute GE compared with healthy controls. Moreover, IL-6 is significantly elevated in bacterial gastroenteritis in comparison to viral gastroenteritis. However, none of these studies included children with severe acute malnutrition.

Severe acute malnutrition (SAM) is a severe form of malnutrition resulting from inadequate or poor quality dietary intake. This is a serious public health problem, particularly in developing countries. SAM can be classified into marasmus, characterized by overt loss of subcutaneous fat and muscle mass, and Kwashiorkor, characterized by bilateral pitting edema of lower limbs.

Malnutrition is one of the most common causes of impaired immune function in children. Malnutrition leads to defects of phagocytosis, chemotactic function of neutrophils and monocytes, complement system and opsonization, and the function of antigen presenting cells.

As part of its negative impact on immune system, SAM may impair acute phase inflammatory response, including cytokines. In vitro studies showed that peripheral blood mononuclear cells from malnourished children have reduced ability to produce cytokines, such as IL-1, IL-6, IL-8, and tumor necrosis factor alpha. Some studies showed that children with SAM have significantly lower levels of IL-6 and IL-8 compared with healthy controls [8]. In contrast, other studies showed similar or higher levels of pro-inflammatory cytokines in malnourished children compared with healthy controls.

To the best of our knowledge, there have been no previous studies on the levels of IL-6 and IL-8 in children with SAM and acute diarrhea.

The aim of this study is to evaluate serum levels of interleukins 6 and 8 in malnourished children with acute diarrhea.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Sohag University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Group 1: Cases (Malnourished children with acute diarrhea)

Inclusion Criteria:

  • 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.

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: Control (Non-malnourished children with acute diarrhea)

Inclusion Criteria:

  • Healthy children aged 6 months to 5 years.
  • Acute diarrhea

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Malnourished children with acute diarrhea
Diagnostic test: 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
Non-malnourished children with acute diarrhea
Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of Interleukin 6
Time Frame: Within the first 3 days of acute diarrhea
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
Time Frame: Within the first 3 days of acute diarrhea
Difference in serum level of interleukin 8 between cases and control groups
Within the first 3 days of acute diarrhea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL6&8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available upon reasonable request

IPD Sharing Time Frame

Immediately after publication

IPD Sharing Access Criteria

Researchers working on relevant field

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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