NCT07160387

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Sep 2025Apr 2027

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2027

Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

August 29, 2025

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

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.

    baseline

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Age from 6 months to 18 years..
  • Both sexes.
  • 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.
  • Clinical suspicion of an underlying gastrointestinal cause (e.g., chronic vomiting, chronic diarrhea either bloody or not, chronic abdominal pain and/or gastrointestinal bleeding
  • Parental/guardian consent for their siblings to share in the study

You may not qualify if:

  • Known chronic disease already causing failure to thrive (genetic, cardiac, renal, or endocrine disorders).
  • Contraindications to endoscopy or anesthesia (e.g. severe coagulopathy, unstable cardiopulmonary status).
  • Parental refusal to participate or consent for endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 36581988BACKGROUND
  • 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.

    PMID: 39489574BACKGROUND
  • 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.

    PMID: 37816587BACKGROUND
  • 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.

    PMID: 39086356BACKGROUND
  • 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.

    PMID: 38923067BACKGROUND
  • 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.

    PMID: 38429959BACKGROUND
  • Smith AE, Shah M, Badireddy M. Failure to Thrive. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459287/

    PMID: 29083644BACKGROUND
  • 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.

    PMID: 34665812BACKGROUND

Related Links

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Ahmed Abdelrady, resident pediatric

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident pediatric

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

September 20, 2025

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

April 20, 2027

Last Updated

September 8, 2025

Record last verified: 2025-08