Ghrelin and Gastric Emptying in Children With Functional Dyspepsia (GHR)
|ClinicalTrials.gov Identifier: NCT01591174|
Recruitment Status : Unknown
Verified February 2015 by Nadia Hijaz, Children's Mercy Hospital Kansas City.
Recruitment status was: Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : February 4, 2015
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||Evaluation of Liquid Gastric Emptying and Plasma Ghrelin in Children With Functional Dyspepsia|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Functional Dyspepsia with PDS
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).
Functional Dyspepsia without 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.
- Children with FD: exploration of relationships between ghrelin concentration, liquid gastric emptying, and dyspepsia subtype [ Time Frame: Duration of 4-hour study visit ]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.
- Children with FD: SUBJECTIVE SYMPTOM SEVERITY and correlations between plasma ghrelin concentrations (acyl and desacyl) and gastric emptying. [ Time Frame: Duration of 4-hour study visit ]Intensity of 5 symptoms associated with FD (burning, nausea, bloating, belching, epigastric pain) will be graded x6 (1 pre and 5 post-meal).
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591174
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Nadia M Hijaz, MD||Fellow, Children's Mercy Hospital, Section of Gastroenterology|