Planned endoscopy due to various diseases other than cancer
Conditions
Interventions
Group 1: Duodenal fluid volume will be collected via endoscopy. The pH and buffer capacity will be measured shortly after obtaining the endoscopy samples.
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Age: Patients 5 - 12 years (all patients within this age range shall participate including 5 and 12 years). 3 patients should be in the age range 5-6 years and 3 patients 11-12 years to ensure coverage of the age range. Sex: Male and female Disease/Illness: Any disease/illness that require endoscopic diagnostics. Health: Participants must be able to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures. Compliance: Participants and participants’ parents understand and are willing, able, and likely to comply with study procedures and restrictions. Consent: Participants and/or participant’s parents are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this study and have given written informed consent and assent where possible.
Exclusion criteria
Exclusion criteria: Disease/Illness: Any diagnosis that contraindicates endoscopy. Patients with cancers are excluded from the study. Nutrition: The patient is instructed to fast for 6 hours before the procedure to ensure an empty stomach.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the characterisation of the duodenal fluid concerning pH, pH buffer capacity, osmolality and concentrations of bile salts, phospholipids, and lipids collected from the 24 patients in the 5-12 years old paediatric population. | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed