An observational study in Functional Dyspepsia, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Children's Mercy Hospital Kansas City · Observational
The main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (FD). The study will also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in FD patients.
Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pediatric patients. The great majority of these patients will have a functional gastrointestinal disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD), defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a structural or biochemical explanation for the pain. The etiology of FD is multifactorial, including biological factors, and these factors can be viewed within a biopsychosocial model. Biological factors include inflammation, dysmotility and increased visceral sensitivity. These biological factors are influenced by and are interactive with psychosocial factors such as anxiety, depression and social interaction. This study will evaluate intestinal permeability as a measure of barrier dysfunction and investigate the correlations between increased permeability, mucosal inflammation and anxiety scores to provide further insight into the etiology of FD, thereby assisting in the development and selection of treatment modalities.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 42 is below the median of 192 across 56 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with chronic abdominal pain.
Exclusion Criteria:
differential sugar absorption test, serum zonulin
Time frame: 5 hour urine collection after administration of test article, serum collected during study visit
Behavioral Assessment Scale for Children (BASC) anxiety scores
Time frame: collected during study visit
T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples
Time frame: collected during biopsy, patient group only
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Children's Mercy Hospital Kansas City