ClinicalTrials.gg
Not yet recruitingNCT07160387Updated Sep 8, 2025

Role of Gastroinestinal Endoscopy in Pediatric Failure to Thrive

An observational study in Failure to Thrive and Endoscope, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
6 Months to 18 Years
Sex
All
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Study summary

This study aims to evaluate the diagnostic role of gastrointestinal endoscopy in children presenting with failure to thrive and its correlation with histopathology and other diagnostic modalities.

Read the detailed description

Failure to thrive (FTT) is a common and concerning clinical presentation in pediatric practice, characterized by inadequate growth or the inability to maintain expected weight and height percentiles (1). By accepted definitions, FTT can be defined as weight-for-age below the 5th percentile, or a drop of two major percentile lines on a standardized growth chart (2). It is not a diagnosis but rather a descriptive term that reflects an underlying issue with inadequate energy intake, absorption, or utilization. The causes of FTT are broad and often multifactorial, ranging from nutritional deficiencies and feeding difficulties to chronic infections, metabolic disorders, and gastrointestinal (GI) diseases. Among these, GI causes are particularly important, as they may be subtle, chronic, and potentially reversible with early diagnosis and appropriate management (3).

Despite advances in nutritional support and non-invasive diagnostics, a subset of children with persistent FTT require further evaluation to identify underlying organic causes (4). Gastrointestinal endoscopy, including esophagogastroduodenoscopy (EGD) and colonoscopy, provides direct visualization, tissue sampling, and diagnosis of a wide spectrum of pathologies such as gastroesophageal reflux disease, eosinophilic esophagitis, celiac disease, inflammatory bowel disease, peptic ulcer disease, and malabsorptive disorders (5).

Children presenting with FTT and associated gastrointestinal symptoms such as persistent vomiting, chronic diarrhea, abdominal pain, dysphagia, feeding intolerance, or hematemesis are particularly likely to benefit from gastrointestinal endoscopy (6). Even in the absence of overt GI symptoms, some children with unexplained FTT may harbor asymptomatic or minimally symptomatic conditions detectable only through endoscopic and histologic examination. Furthermore, gastrointestinal endoscopy can also help to rule out serious pathologies and provide reassurance to caregivers, allowing clinicians to focus on non-organic or psychosocial contributors to FTT when appropriate (7).

Despite its clinical utility, the use of gastrointestinal endoscopy in evaluation of FTT must be carefully considered due to its invasive nature, the need for sedation or anesthesia, and potential complications (8). Therefore, patient selection and risk-benefit ratio assessment are crucial. The decision to perform gastrointestinal endoscopy is often guided by a combination of clinical findings, laboratory data, growth patterns, and failure to respond to initial nutritional interventions (9).

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Conditions studied

  • Failure to Thrive
  • Endoscope

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In context

Failure to Thrive

84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.

This study's planned enrollment of 50 is below the median of 165 across 24 observational studies indexed under Failure to Thrive.

Browse Failure to Thrive studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

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

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Study population

any child from6 months to 18 years and has unexplained failure to thrive failure to thrive means: Weight-for-age below the 5th percentile for sex/age or crossing downward by ≥2 major percentiles lines on a standardized growth chart confirmed on two measurements.

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

  1. Age from 6 months to 18 years..
  2. Both sexes.
  3. Diagnosed with failure to thrive, defined as :

    Weight-for-age below the 5th percentile for sex/age or crossing downward by ≥2 major percentiles, confirmed on two measurements.

  4. Clinical suspicion of an underlying gastrointestinal cause (e.g., chronic vomiting, chronic diarrhea either bloody or not, chronic abdominal pain and/or gastrointestinal bleeding
  5. Parental/guardian consent for their siblings to share in the study

Exclusion criteria

Exclusion Criteria:

  1. Known chronic disease already causing failure to thrive (genetic, cardiac, renal, or endocrine disorders).
  2. to endoscopy or anesthesia (e.g. severe coagulopathy, unstable cardiopulmonary status).
  3. Parental refusal to participate or consent for endoscopy
Terms in these criteria, in plain language(1)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Role of Gastrointestinal Endoscopy in Evaluation of Pediatric Failure to Thrive

    evaluate the diagnostic role of gastrointestinal endoscopy in children presenting with failure to thrive and its correlation with histopathology and other diagnostic modalities.

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Burayzat S, Odeh M, Altamimi E, Al-Dweik S, El Wahab K, Alanasweh M, Al-Khraisat M, Barqawi M. Eesophagogastroduodenoscopy in paediatrics: does abiding by the international guidelines lead to appropriate management? A cross-sectional study. BMJ Open. 2022 Sep 1;12(9):e061489. doi: 10.1136/bmjopen-2022-061489. PubMed 36581988 ↗
  • Ngo PD, Lightdale JR. Advances in Pediatric Endoscopy. Gastroenterol Clin North Am. 2024 Dec;53(4):539-555. doi: 10.1016/j.gtc.2024.08.010. Epub 2024 Sep 30. PubMed 39489574 ↗
  • Sidhu R, Turnbull D, Haboubi H, Leeds JS, Healey C, Hebbar S, Collins P, Jones W, Peerally MF, Brogden S, Neilson LJ, Nayar M, Gath J, Foulkes G, Trudgill NJ, Penman I. British Society of Gastroenterology guidelines on sedation in gastrointestinal endoscopy. Gut. 2024 Jan 5;73(2):219-245. doi: 10.1136/gutjnl-2023-330396. PubMed 37816587 ↗
  • Lawson NR, Angelo J, Chiou E, Glinton K, Dean A. Failure to Thrive, Metabolic Acidosis, and Diarrhea in a 7-Week-Old Infant. Pediatrics. 2024 Sep 1;154(3):e2023064240. doi: 10.1542/peds.2023-064240. PubMed 39086356 ↗
  • Amil-Dias J, Oliva S, Papadopoulou A, Thomson M, Gutierrez-Junquera C, Kalach N, Orel R, Auth MK, Nijenhuis-Hendriks D, Strisciuglio C, Bauraind O, Chong S, Ortega GD, Fernandez SF, Furman M, Garcia-Puig R, Gottrand F, Homan M, Huysentruyt K, Kostovski A, Otte S, Rea F, Roma E, Romano C, Tzivinikos C, Urbonas V, Velde SV, Zangen T, Zevit N. Diagnosis and management of eosinophilic esophagitis in children: An update from the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2024 Aug;79(2):394-437. doi: 10.1002/jpn3.12188. Epub 2024 Jun 24. PubMed 38923067 ↗
  • McDonald CM, Reid EK, Pohl JF, Yuzyuk TK, Padula LM, Vavrina K, Altman K. Cystic fibrosis and fat malabsorption: Pathophysiology of the cystic fibrosis gastrointestinal tract and the impact of highly effective CFTR modulator therapy. Nutr Clin Pract. 2024 Apr;39 Suppl 1:S57-S77. doi: 10.1002/ncp.11122. PubMed 38429959 ↗
  • Smith AE, Shah M, Badireddy M. Failure to Thrive. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459287/ PubMed 29083644 ↗
  • Lin YC, Yen HR, Tsai FJ, Wang CH, Chien LC, Chen AC, Lin RT. Effects of cyproheptadine on body weight gain in children with nonorganic failure to thrive in Taiwan: A hospital-based retrospective study. PLoS One. 2021 Oct 19;16(10):e0258731. doi: 10.1371/journal.pone.0258731. eCollection 2021. PubMed 34665812 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Mar 2027, 18 months later.

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

Registered
Aug 29, 2025
First posted
Sep 8, 2025
StartEst.
Sep 20, 2025
Primary completionEst.
Mar 20, 2027
CompletionEst.
Apr 20, 2027
Last update
Sep 8, 2025
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, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07160387
Lead sponsor
Assiut University
Responsible party
Mohamed Ahmed Abdelrady Abdelmalek (resident pediatric, Assiut University) — Principal investigator
First posted
Sep 8, 2025
Start date
Sep 20, 2025 (estimated)
Primary completion
Mar 20, 2027 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
Sep 8, 2025

Study contacts

Mohamed Ahmed Abdelrady, resident pediatric
Contact
drrady2022@gmail.com
+201097225957

Oversight

Data monitoring committee
Yes
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 Aug 2025. You cannot join it, but the record below documents what was studied.

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