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Clinical Trials/NCT05183789
NCT05183789RecruitingNot Applicable

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

Sohag University1 site in 1 country60 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Serum level of Interleukin 6

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
6 Months to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Motaz Mohamed Hassan

Pediatric Resident

Sohag University

Study Sites (1)

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