NCT01591174|Completed
Ghrelin and Gastric Emptying in Children With Functional Dyspepsia
GHR
Evaluation of Liquid Gastric Emptying and Plasma Ghrelin in Children With Functional Dyspepsia
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GHR
Evaluation of Liquid Gastric Emptying and Plasma Ghrelin in Children With Functional Dyspepsia
Sponsor study identifier
observational
30
1 country
1
Study Start
May 2012
Actual (reported)Primary Completion
April 22, 2016
Actual (reported)Study Completion
April 22, 2016
Actual (reported)The purpose of this research is to see if there are differences between children who have FD and children without FD in the ability of the stomach to empty food and/or in ghrelin hormone levels before and after eating. Chronic abdominal pain is the most common persistent pain condition in children and adolescents. One of the most often diagnosed types of abdominal pain is functional dyspepsia (FD). FD is abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that does not get better by having a bowel movement. One possible explanation for having FD is a delay in the emptying of food from the stomach, or delayed gastric (stomach) emptying. Failing to empty the stomach quickly enough may result in the feeling of being full and cause symptoms of bloating, nausea, vomiting and pain. Further, hormonal changes occur before, during, or after eating food that appear to impact stomach emptying. One of the hormones that changes with meals is called ghrelin. The relationship between ghrelin and stomach emptying needs to be explored more in children with FD. Better understanding of what causes FD symptoms may help us to improve treatment for this condition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 22, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Actual (reported)May 2, 2012
Actual (reported)May 3, 2012
Actual (reported)April 22, 2016
Actual (reported)April 22, 2016
Actual (reported)Children with FD: exploration of relationships between ghrelin concentration, liquid gastric emptying, and dyspepsia subtype
Blood samples will be compared pre/post test meal for FD cohorts (EPS/PDS), controls: 0 time/baseline; 6 times/post meal. Associations between relationship of plasma ghrelin type's (acyl and desacyl) pre and postprandial levels \& gastric emptying studied.C-13 acetate to be given and amount of 13CO2 determined for each time point (1 pre/ 14 post meal) using equation nested in software package with UBit IR-300 spectrometer. The concentration of 13CO2 and 12CO2 in the exhaled breath samples to be measured by infrared spectrometry.
Duration of 4-hour study visit
Children with FD: SUBJECTIVE SYMPTOM SEVERITY and correlations between plasma ghrelin concentrations (acyl and desacyl) and gastric emptying.
Duration of 4-hour study visit
Study participants 8-17 years of age will be recruited for this arm after an evaluation at Children's Mercy Hospital and Clinics in the Abdominal Pain Clinic (APC)or in the Section of Gastroenterology, general, and diagnosed with FD, fail to respond to acid suppression therapy and have Postprandial Distress Syndrome (PDS).
Study participants 8-17 years of age will be recruited for this arm after an evaluation at Children's Mercy Hospital and clinics (CMH) Abdominal Pain Clinic (APC)or the Section of Gastroenterology, general, and diagnosed with FD, fail to respond to acid suppression therapy and do not have Postprandial Distress Syndrome (PDS).
Healthy participants 8-17 years of age recruited from internal advertising within Children's Mercy Hospital and Clinics.
All FD patients will be recruited from the Section of Gastroenterology at the Children's Mercy Hospital and Clinics. The control group will be recruited by advertisement within Children's Mercy Hospital.
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
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breath specimen blood plasma
Nadia M Hijaz, MD
Fellow, Children's Mercy Hospital, Section of Gastroenterology
30 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2012
First Posted
May 3, 2012
Study Start
May 2012
Actual (reported)Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia
Contact the study team to confirm eligibility.
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Primary Completion
April 22, 2016
Actual (reported)Study Completion
April 22, 2016
Actual (reported)Last Updated
May 20, 2019
Record last verified: 2019-05
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