ClinicalTrials.gg
Not yet recruitingNCT07807527Updated Sep 8, 2026

Fecal Calprotectin in Pediatric Gastrointestinal Disorders

An observational study in Gastrointestinal Diseases and Inflammatory Bowel Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Primary conditionInflammatory Bowel DiseasesRegistry: Gastrointestinal DiseasesReclassifiedWhy we changed it
Registry
Gastrointestinal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Inflammatory Bowel Diseases
Why
  1. The study's listed conditions name Inflammatory Bowel Diseases, a narrower term within Gastrointestinal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
2 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 45 studies in Inflammatory Bowel Diseases by Assiut University — 20 open to participants now, 20 under way, none of them phase 3. Inflammatory Bowel Diseases · Assiut University.

Planned enrollment
8th of 41
120 · median 100
Started
2026
with 11 others
Observational
41 of 45
19 open now
Primary completion
2027-09
later than 11 of 19 live
Registered
41st of 45
by date

Among the 45 studies in Inflammatory Bowel Diseases by Assiut University, this one is the 8th largest by planned enrollment of the 41 observational ones that give a count, is one of 12 that started in 2026, is one of 41 observational ones, reaches primary completion later than 11 of the 19 other live ones, and was the 41st registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

20 of the 45 studies in Inflammatory Bowel Diseases by Assiut University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 2 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Inflammatory Bowel Diseases by Assiut University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Gastrointestinal Diseases
  • Inflammatory Bowel Diseases

Browse trials for

Keywords

  • Fecal calprotectin
  • Pediatric
  • Endoscopy
  • Histopathology
04

In context

Inflammatory Bowel Diseases Reclassified

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

This study's planned enrollment of 120 is below the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Inflammatory Bowel Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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
  • Written from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • Age below 2 years
  • Use of NSAIDs, systemic , or antibiotics within 4 weeks before stool sampling
  • Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation
  • Previous gastrointestinal surgery, known , chronic liver disease, chronic kidney disease, or cystic fibrosis
  • Refusal of parents or legal guardians to participate
  • Failure to obtain an adequate stool sample
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. Correlation with endoscopic findings

    Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).

    Time frame: Baseline

  2. Correlation with histopathological findings

    Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.

    Time frame: Baseline

  3. Optimal cutoff value of fecal calprotectin

    Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.

    Time frame: Baseline

08

Study locations

No study locations are listed for this record.

09

References and documents

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 38944519 ↗
  • Dalla 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 33878738 ↗
  • Rohani 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 36180889 ↗
  • Moreira 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 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartEst.
Sep 2, 2026
Primary completionEst.
Sep 2, 2027
CompletionEst.
Aug 1, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07807527
Lead sponsor
Assiut University
Responsible party
Manar Helmy Mohamed (Resident Physician department of pediatrics, Assiut University) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 2, 2026 (estimated)
Primary completion
Sep 2, 2027 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Manar H Mohamed, Resident
Contact
Manar.18313532@med.aun.edu.eg
+20 12 23691268
Zeinab m Mohieldeen, prof
study chair · Pediatric Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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