Failure to ThriveNCT07160387
Role of Gastroinestinal Endoscopy in Pediatric Failure to Thrive
An observational study of Failure to Thrive and Endoscope, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Failure to Thrive, Endoscope
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 20 Apr 2027
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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: Role of Gastrointestinal Endoscopy in Evaluation of Pediatric Failure to Thrive
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).
- Conditions
- Failure to Thrive, Endoscope
- Medical subject headings
- Failure to Thrive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Failure to ThriveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelrady Abdelmalek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160387
- Sponsor's protocol ID
- GIT endoscopy in children FTT
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36581988Ngo 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 39489574Sidhu 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 37816587Lawson 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 39086356Amil-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 38923067McDonald 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 38429959Smith 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 29083644Lin 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gastrointestinal Endoscopy in Evaluation of Pediatric Failure to Thrive
- ClinicalTrials.gov ID
- NCT07160387
- Acronym / sponsor ID
- GIT endoscopy in children FTT
- Conditions
- Failure to Thrive, Endoscope
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 8 Sep 2025 (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 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
Role of Gastrointestinal Endoscopy in Evaluation of Pediatric Failure to Thrive
Time frame: baseline
evaluate the diagnostic role of gastrointestinal endoscopy in children presenting with failure to thrive and its correlation with histopathology and other diagnostic modalities.
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 2025.
- Results publication: PubMed 36581988Burayzat 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.
- Results publication: PubMed 39489574Ngo 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.
- Results publication: PubMed 37816587Sidhu 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.
- Results publication: PubMed 39086356Lawson 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.
- Results publication: PubMed 38923067Amil-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.
- Results publication: PubMed 38429959McDonald 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.
- Results publication: PubMed 29083644Smith 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/
- Results publication: PubMed 34665812Lin 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.
- Endoscopic biopsies - The gastrointestinal undercover agent!Link provided by the sponsor.
- Weight-Faltering in Infants and Children (Failure to Thrive)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Failure to Thrive and Endoscope, 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 6 inclusion and 3 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 2025. 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 Mohamed Ahmed Abdelrady, resident pediatric (+201097225957, drrady2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of Gastrointestinal Endoscopy in Evaluation of Pediatric Failure to Thrive (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 NCT07160387, which also lists 8 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 2025.