Acute DiarrheaNCT05183789
IL6&8 in Malnourished Children With Acute Diarrhea
An observational study of Acute Diarrhea and Severe Acute Malnutrition, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Diarrhea, Severe Acute Malnutrition, Acute Gastroenteritis
- What is being tested?
- Evaluation of serum levels of IL-6 and IL-8
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children presented to the Pediatric Department and Outpatient Clinic at Sohag University Hospital
Who may be able to join
- 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.
- Healthy children aged 6 months to 5 years.
- Acute diarrhea
Who cannot join
- 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
Show all 16Show fewer
- Diabetes mellitus
- Group 2: Control (Non-malnourished children with 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, 82524
Mostafa Abo-Sidera, MD, PhD, 00201002028668, aabosdera@yahoo.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Evaluation of serum levels of IL-6 and IL-8
- Keywords
- Children, Acute diarrhea, Severe acute malnutrition, Interleukins, Cytokines
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of serum levels of IL-6 and IL-8Diagnostic test
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits).
| Study group | Role | What they receive |
|---|---|---|
| Cases | Malnourished children with acute diarrhea Receives: Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8 | |
| Control | Non-malnourished children with acute diarrhea Receives: Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of Interleukin 6
Difference in serum level of interleukin 6 between cases and control groups
Measured: 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
Measured: Within the first 3 days of acute diarrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motaz Mohamed Hassan, Sohag University
- Investigators
- Abdelrahim A Sadek, MD, PhD, Study chair, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183789
- Sponsor's protocol ID
- IL6&8
- Status last verified
- Sep 2022
- First submitted
- 21 Dec 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon reasonable request
Publications
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.
PubMed 32274357Rankin JA. Biological mediators of acute inflammation. AACN Clin Issues. 2004 Jan-Mar;15(1):3-17. doi: 10.1097/00044067-200401000-00002.
PubMed 14767362Svanborg 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.
PubMed 10047563Chen 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.
PubMed 23899552Ibrahim 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.
PubMed 28768707Marginean 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.
PubMed 24398988Dulger 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.
PubMed 12581501Malave 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.
PubMed 9819485
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Interleukins 6 and 8 in Malnourished Children With Acute Diarrhea
- ClinicalTrials.gov ID
- NCT05183789
- Acronym / sponsor ID
- IL6&8
- Keywords
- Children, Acute diarrhea, Severe acute malnutrition, Interleukins, Cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8Malnourished children with acute diarrhea |
| Control | – | Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8Non-malnourished children with acute diarrhea |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children presented to the Pediatric Department and Outpatient Clinic at Sohag University Hospital
Key inclusion criteria (5 listed)
- 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.
- Healthy children aged 6 months to 5 years.
- Acute diarrhea
Key exclusion criteria (16 listed)
- History of antibiotic therapy in the last 72 hours.
- Acute diarrhea in association with systemic infections
- Malignancy
- Chronic diarrhea
- Autoimmune and autoinflammatory diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of serum levels of IL-6 and IL-8Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits). | Diagnostic test | Cases, Control |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 32274357Zaki 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.
- Background: PubMed 14767362Rankin JA. Biological mediators of acute inflammation. AACN Clin Issues. 2004 Jan-Mar;15(1):3-17. doi: 10.1097/00044067-200401000-00002.
- Background: PubMed 10047563Svanborg 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.
- Background: PubMed 23899552Chen 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.
- Background: PubMed 28768707Ibrahim 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.
- Background: PubMed 24398988Marginean 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.
- Background: PubMed 12581501Dulger 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.
- Background: PubMed 9819485Malave 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.
- Individual participant dataSharing planned: Yes. IPD will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrahim A Sadek, MD, PhD study chair
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diarrhea and Severe Acute Malnutrition, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Motaz Hassan, MBBCH (00201023286623, motaz011193@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of Interleukin 6 (time frame: Within the first 3 days of acute diarrhea). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183789, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.