Acute GastroenteritisNCT05213325
Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis
An observational study of Acute Gastroenteritis and Acute Diarrhea, 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. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Gastroenteritis, Acute Diarrhea
- What is being tested?
- Evaluation of serum levels of IL-6 and IL-8
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Dec 2022
- 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
- Children aged 6 months to 5 years.
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- Chronic renal/liver failure
- Diabetes mellitus
- Group 2: Controls (Healthy control children)
- 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.
Ashraf M Radwan, MD, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
Official title: Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis
Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.
- Conditions
- Acute Gastroenteritis, Acute Diarrhea
- Being tested
- Evaluation of serum levels of IL-6 and IL-8
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 | Children with acute diarrhea Receives: Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8 | |
| Control | Healthy control children 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 posted28 Jan 2022
- Study start15 Dec 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies 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, John Samuel Shaker, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213325
- Sponsor's protocol ID
- Soh-Med-21-12-07
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhsen K, Kassem E, Rubenstein U, Goren S, Ephros M, Shulman LM, Cohen D. No evidence of an increase in the incidence of norovirus gastroenteritis hospitalizations in young children after the introduction of universal rotavirus immunization in Israel. Hum Vaccin Immunother. 2019;15(6):1284-1293. doi: 10.1080/21645515.2019.1599522. Epub 2019 May 3.
PubMed 30945960Chen 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 23899552Hamiel U, Bahat H, Kozer E, Hamiel Y, Ziv-Baran T, Goldman M. Diagnostic markers of acute infections in infants aged 1 week to 3 months: a retrospective cohort study. BMJ Open. 2018 Jan 24;8(1):e018092. doi: 10.1136/bmjopen-2017-018092.
PubMed 29371270
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis
- ClinicalTrials.gov ID
- NCT05213325
- Acronym / sponsor ID
- Soh-Med-21-12-07
- Conditions
- Acute Gastroenteritis, Acute Diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 28 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. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.
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-8Children with acute diarrhea |
| Control | – | Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8Healthy control children |
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 (3 listed)
- Children aged 6 months to 5 years.
- 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.
Key exclusion criteria (18 listed)
- Malnutrition or obesity
- History of antibiotic therapy in the last 72 hours.
- Acute diarrhea in association with systemic infections
- Malignancy
- Chronic diarrhea
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 28 Jan 2022.
- Background: PubMed 30945960Muhsen K, Kassem E, Rubenstein U, Goren S, Ephros M, Shulman LM, Cohen D. No evidence of an increase in the incidence of norovirus gastroenteritis hospitalizations in young children after the introduction of universal rotavirus immunization in Israel. Hum Vaccin Immunother. 2019;15(6):1284-1293. doi: 10.1080/21645515.2019.1599522. Epub 2019 May 3.
- 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 29371270Hamiel U, Bahat H, Kozer E, Hamiel Y, Ziv-Baran T, Goldman M. Diagnostic markers of acute infections in infants aged 1 week to 3 months: a retrospective cohort study. BMJ Open. 2018 Jan 24;8(1):e018092. doi: 10.1136/bmjopen-2017-018092.
- Individual participant dataSharing planned: No
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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.
Ashraf M Radwan, MD, PhD contact
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 Gastroenteritis and Acute Diarrhea, 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 3 inclusion and 18 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 28 Jan 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 John s shaker, MBBCH (012057258026, johnshaker@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 NCT05213325, which also lists 3 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 28 Jan 2022.