K58.1 R10.4 R10 K59.9 K30 K58.2 K58.3 K58
Conditions
Interventions
Group 1: Children and adolsecents with functional abdominal pain disorders (FAPD) from 6 to 18 years of age.
Group 2: Children and adolescents from 6 to 18 years of age without functional abdominal pa
Sponsors
Zentrum für Kinder- und Jugendmedizin HELIOS Universitätsklinikum Wuppertal, Universität Witten/Herdecke
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Written informed consent of the legal guardians as well as assent of the participants for study participation and data protection after appropriate briefing Age 6–18 years FAPD group: Chronic abdominal pain (>2 months) with or without defecation disorders, after exclusion of other somatic causes Control group: No chronic or recurrent abdominal complaints Last antibiotic therapy more than 2 months ago No somatic gastrointestinal disease (celiac disease, IBD, acute gastrointestinal infection, gastritis, lactose/fructose intolerance) No acute infection
Exclusion criteria
Exclusion criteria: Age 18 years FAPD group: Does not meet diagnostic criteria according to Rome IV Control group: Chronic or recurrent abdominal pain Last antibiotic therapy less than 2 months ago Somatic gastrointestinal disease (celiac disease, IBD, acute gastrointestinal infection, gastritis, lactose/fructose intolerance) Acute infection, fever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of clinical symptom burden and subgroup characteristics of pediatric abdominal pain syndromes using the Pediatric Quality of Life Inventory (PedsQL). 2. Analysis of oral and intestinal microbiome composition through 16S rRNA gene sequencing. 3. Determination of vesicular miRNA profiles using the ExoQuick isolation method followed by high-throughput sequencing. 4. Correlation analysis of endpoints 1–3 through exploratory subgroup analyses applying dimensionality reduction techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary endpoint, intestinal barrier function will be analyzed using an in vitro cell culture model. Functional assessment will include transepithelial electrical resistance (TEER) measurements. In addition, downstream omics analyses will be performed to investigate the effects of microbial metabolites on barrier properties in co-culture models with microbial stimuli. Tertiary, metatranscriptomic analyses are implemented for the functional characterization of the microbiome. | — |
Countries
Germany
Contacts
Public ContactKai Hensel
Zentrum für Kinder- und Jugendmedizin HELIOS Universitätsklinikum Wuppertal, Universität Witten/Herdecke
Outcome results
None listed