Ghrelin and Gastric Emptying in Children With Functional Dyspepsia

NCT01591174 | Completed

• 1 other identifier: Ghrelin 12010078
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia; Postprandial Distress Syndrome; ghrelin; C-13 acetate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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 Arms (3)

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).

Control Group

Healthy participants 8-17 years of age recruited from internal advertising within Children's Mercy Hospital and Clinics.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• All: Participants 8-17 years of age

You may not qualify if:

• History of upper gastrointestinal surgery or intestinal obstruction.
• History of disease or symptoms suggestive of underlying malabsorption, Inflammatory Bowel Disease (IBD), or Peptic Ulcer Disease (PUD).
• History or evidence of chronic illness requiring regular medical care such as diabetes mellitis (DM), liver, heart, kidney, endocrine, or pulmonary disease and asthma that precludes accurate exhalation into the study breath collection apparatus.
• Any patient with body Mass index (BMI) less than or equal to 10th percentile for age; or equal to or greater than 90th percentile for age.
• Patient and/or parent not able to read English.
• Current pregnancy.
• History of milk allergy.
• Prokinetic or psychotropic medications used within the last 72 hour prior to study.
• Inability to exhale into study breath collection apparatus as directed.
• Recent acute illness that occurs prior to study visit.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

breath specimen blood plasma

Study Officials

• Nadia M Hijaz, MD

  Fellow, Children's Mercy Hospital, Section of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Fellow, Children's Mercy Hospital, Section of Gastroenterology

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 3, 2012
• Study Start: May 1, 2012
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

US (1)