Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05183789
Study type Observational
Source Sohag University
Contact Motaz Hassan, MBBCH
Phone 00201023286623
Email [email protected]
Status Not yet recruiting
Phase
Start date January 2022
Completion date January 2023

See also
  Status Clinical Trial Phase
Completed NCT04682860 - Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide Phase 4
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT01577043 - Efficacy of Racecadotril in Acute Watery Diarrhea in Children Phase 4
Completed NCT03234777 - Evaluating a Knowledge Translation Tool for Parents N/A
Not yet recruiting NCT02619201 - Antiemetic Efficacy of Ondansetron Versus Metoclopramide Phase 3
Completed NCT02280759 - Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children. Phase 1
Completed NCT02025452 - Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis Phase 4
Completed NCT02803827 - Optimizing the Management of Acute Diarrhoeal Disease Phase 3
Completed NCT02644200 - Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis Phase 3
Completed NCT02174874 - Ondansetron Oral Versus Orally Disintegrating Tablets (ODT) N/A
Completed NCT03539913 - Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children Phase 4
Completed NCT04463355 - Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department N/A
Completed NCT04555200 - Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis
Completed NCT02169817 - Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children Phase 4
Unknown status NCT02177799 - Surveillance Study of Acute Gastroenteritis in Hospitalized Children in Rural Area in Lebanon N/A
Completed NCT01886755 - Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis N/A
Completed NCT01257672 - Symptomatic Treatment of Acute Gastroenteritis Phase 3
Completed NCT01571856 - Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Phase 4
Completed NCT01871038 - Rotarix Vaccine Effectiveness N/A
Completed NCT05076461 - Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children N/A