Actively Recruiting
Physiopathology of Dumping Syndrome in Esophageal Atresia
Led by University Hospital, Lille · Updated on 2025-12-23
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
G
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Dumping syndrome (DS) often occurs in infants with oesophageal atresia, affecting about 29% and causing dangerous low blood sugar levels after meals. This condition is hard to diagnose because symptoms appear inconsistently after eating. Currently, only symptom relief treatments exist. The study aims to better understand the causes of DS to improve treatment and prevent complications in infants born with oesophageal atresia. The study involves infants aged 2 to 3 months who were born with oesophageal atresia type C. Participants will undergo continuous blood sugar monitoring using a Glycemic Holter, continuous heart monitoring with a Holter ECG, and a gastric emptying scintigraphy test that tracks how quickly the stomach empties after feeding. The gastric emptying test involves drinking a milk bottle labeled with a safe radioactive marker and having a camera measure remaining radioactivity every 30 minutes for 4 hours. During the study, infants will be observed for abnormal blood sugar levels linked to nerve activity and stomach emptying over 48 hours. Researchers will also check if dumping syndrome persists at 6 months and assess how well infants tolerate the glucose monitoring. The total study period covers monitoring and follow-up assessments to better understand DS mechanisms and its effects on these infants.
CONDITIONS
Brief Title
Dumping Syndrome and Esophageal Atresia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients operated at birth for Oesophageal atresia type C
- Aged from 2 to 3 months at inclusion
- Off prokinetic treatment (suspended for at least 72 hours) before monitoring
You will not qualify if you...
- History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia)
- History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabetes)
- Treatment that can modify gastric motility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants undergo continuous glycemic and cardiac monitoring using wearable devices along with gastric emptying scintigraphy to assess digestive function.
1 monitoring period lasting 48 hours with device use and 1 imaging session
Duration - Up to 6 months
Participants are followed up at 6 months to assess persistence of dumping syndrome.
1 follow-up visit at 6 months
Trial Site Locations
Total: 2 locations
1
Hôpital Jeanne de Flandres
Lille, France, 59037
Not Yet Recruiting
2
Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille
Lille, France
Actively Recruiting
Research Team
M
Madelaine AUMAR, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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