Gastrointestinal DiseasesNCT07807527
Fecal Calprotectin in Pediatric Gastrointestinal Disorders
An observational study of Gastrointestinal Diseases and Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
This prospective cross-sectional study aims to evaluate the diagnostic value of fecal calprotectin as a non-invasive biomarker in children with gastrointestinal disorders and to assess its correlation with endoscopic and histopathological findings at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Gastrointestinal Diseases, Inflammatory Bowel Diseases
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 1 Aug 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 2 to 18 years presenting with chronic or recurrent gastrointestinal symptoms and scheduled for endoscopic evaluation at the Pediatric Gastroenterology and Endoscopy Units, Assiut University Children Hospital.
Who may be able to join
- - Age 2 to 18 years
- Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive)
- Scheduled for upper gastrointestinal endoscopy and/or ileocolonoscopy with mucosal biopsy
- Written informed consent from parents or legal guardians
Who cannot join
- Age below 2 years
- Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling
- Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation
- Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis
- Refusal of parents or legal guardians to participate
- Failure to obtain an adequate stool sample
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings
This prospective cross-sectional study aims to evaluate the diagnostic value of fecal calprotectin as a non-invasive biomarker in children with gastrointestinal disorders and to assess its correlation with endoscopic and histopathological findings at Assiut University Children Hospital.
Read the detailed description
Gastrointestinal symptoms such as chronic abdominal pain, persistent diarrhea, and rectal bleeding are common reasons for referral to pediatric gastroenterology clinics. Distinguishing organic inflammatory disease from functional disorders remains a diagnostic challenge.
Fecal calprotectin is a non-invasive marker of intestinal inflammation. This study will include children aged 2 to 18 years with chronic or recurrent gastrointestinal symptoms who are scheduled for endoscopic evaluation. Fecal calprotectin levels will be measured and compared with endoscopic and histopathological findings to determine diagnostic performance, including sensitivity, specificity, and optimal cutoff values.
- Keywords
- Fecal calprotectin, Pediatric, Endoscopy, Histopathology
- Medical subject headings
- Gastrointestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single group: Children with gastrointestinal symptoms undergoing endoscopy | Children aged 2-18 years with chronic or recurrent gastrointestinal symptoms who will undergo fecal calprotectin measurement and endoscopic evaluation with mucosal biopsy as part of routine diagnostic work-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of fecal calprotectin
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve of fecal calprotectin for detecting mucosal inflammation, using endoscopic and histopathological findings as the reference standard.
Measured: Baseline
Secondary outcomes (3)
Correlation with endoscopic findings
Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).
Measured: Baseline
Correlation with histopathological findings
Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.
Measured: Baseline
Optimal cutoff value of fecal calprotectin
Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion2 Sep 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Helmy Mohamed, Assiut University
- Investigators
- Zeinab m Mohieldeen, prof, Study chair, Pediatric Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807527
- Sponsor's protocol ID
- FC-Pediatric-GI-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Memish ZA, Zumla A, Madhi SA, Al Rabeeah AA. Novel funding pledges for advancing polio eradication efforts. Lancet. 2024 Jun 29;403(10446):2781-2782. doi: 10.1016/S0140-6736(24)01026-2. No abstract available.
PubMed 38944519Dalla Lana Semione G, Vonk V, Pandey AD, Granas E, Arndt B, Wenskat M, Hillert W, Noei H, Stierle A. Temperature-dependent near-surface interstitial segregation in niobium. J Phys Condens Matter. 2021 May 24;33(26). doi: 10.1088/1361-648X/abf9b7.
PubMed 33878738Rohani P, Beheshti NR, Alimadadi H, Sohouli MH. Association of fecal calprotectin level with eosinophilic gastrointestinal disease in Iranian pediatrics. Allergy Asthma Clin Immunol. 2022 Sep 30;18(1):86. doi: 10.1186/s13223-022-00728-5.
PubMed 36180889Moreira RT, Rodrigues LARL, Farias LM, Crisostomo JM, Lavor LCC, Rodrigues Filho OS, Frota KMG. Effect of vitamin D supplementation on depression treatment. Rev Assoc Med Bras (1992). 2021 Aug;67(8):1192-1197. doi: 10.1590/1806-9282.20210404. No abstract available.
PubMed 34669869
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings
- ClinicalTrials.gov ID
- NCT07807527
- Acronym / sponsor ID
- FC-Pediatric-GI-Assiut-2026
- Keywords
- Fecal calprotectin, Pediatric, Endoscopy, Histopathology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 8 Sep 2026 (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.
This prospective cross-sectional study aims to evaluate the diagnostic value of fecal calprotectin as a non-invasive biomarker in children with gastrointestinal disorders and to assess its correlation with endoscopic and histopathological findings at Assiut University Children Hospital.
Detailed description
Gastrointestinal symptoms such as chronic abdominal pain, persistent diarrhea, and rectal bleeding are common reasons for referral to pediatric gastroenterology clinics. Distinguishing organic inflammatory disease from functional disorders remains a diagnostic challenge.
Fecal calprotectin is a non-invasive marker of intestinal inflammation. This study will include children aged 2 to 18 years with chronic or recurrent gastrointestinal symptoms who are scheduled for endoscopic evaluation. Fecal calprotectin levels will be measured and compared with endoscopic and histopathological findings to determine diagnostic performance, including sensitivity, specificity, and optimal cutoff values.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group: Children with gastrointestinal symptoms undergoing endoscopy | – | –Children aged 2-18 years with chronic or recurrent gastrointestinal symptoms who will undergo fecal calprotectin measurement and endoscopic evaluation with mucosal biopsy as part of routine diagnostic work-up. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 2 to 18 years presenting with chronic or recurrent gastrointestinal symptoms and scheduled for endoscopic evaluation at the Pediatric Gastroenterology and Endoscopy Units, Assiut University Children Hospital.
Key inclusion criteria (4 listed)
- - Age 2 to 18 years
- Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive)
- Scheduled for upper gastrointestinal endoscopy and/or ileocolonoscopy with mucosal biopsy
- Written informed consent from parents or legal guardians
Key exclusion criteria (6 listed)
- Age below 2 years
- Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling
- Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation
- Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis
- Refusal of parents or legal guardians to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of fecal calprotectin
Time frame: Baseline
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve of fecal calprotectin for detecting mucosal inflammation, using endoscopic and histopathological findings as the reference standard.
3 secondary outcomes
Correlation with endoscopic findings
Time frame: Baseline
Correlation with histopathological findings
Time frame: Baseline
Optimal cutoff value of fecal calprotectin
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 38944519Memish ZA, Zumla A, Madhi SA, Al Rabeeah AA. Novel funding pledges for advancing polio eradication efforts. Lancet. 2024 Jun 29;403(10446):2781-2782. doi: 10.1016/S0140-6736(24)01026-2. No abstract available.
- Background: PubMed 33878738Dalla Lana Semione G, Vonk V, Pandey AD, Granas E, Arndt B, Wenskat M, Hillert W, Noei H, Stierle A. Temperature-dependent near-surface interstitial segregation in niobium. J Phys Condens Matter. 2021 May 24;33(26). doi: 10.1088/1361-648X/abf9b7.
- Background: PubMed 36180889Rohani P, Beheshti NR, Alimadadi H, Sohouli MH. Association of fecal calprotectin level with eosinophilic gastrointestinal disease in Iranian pediatrics. Allergy Asthma Clin Immunol. 2022 Sep 30;18(1):86. doi: 10.1186/s13223-022-00728-5.
- Background: PubMed 34669869Moreira RT, Rodrigues LARL, Farias LM, Crisostomo JM, Lavor LCC, Rodrigues Filho OS, Frota KMG. Effect of vitamin D supplementation on depression treatment. Rev Assoc Med Bras (1992). 2021 Aug;67(8):1192-1197. doi: 10.1590/1806-9282.20210404. No abstract available.
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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.
Zeinab m Mohieldeen, prof study chair
Pediatric Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases and Inflammatory Bowel Diseases, run by Assiut University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar H Mohamed, Resident (+20 12 23691268, Manar.18313532@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of fecal calprotectin (time frame: Baseline). 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 NCT07807527, which also lists 4 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 8 Sep 2026.