Ghrelin and Gastric Emptying in Children With Functional Dyspepsia (GHR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Nadia Hijaz, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01591174
First received: May 2, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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
Functional Dyspepsia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Liquid Gastric Emptying and Plasma Ghrelin in Children With Functional Dyspepsia

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Children with FD: exploration of relationships between ghrelin concentration, liquid gastric emptying, and dyspepsia subtype [ Time Frame: Duration of 4-hour study visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

breath specimen blood plasma


Estimated Enrollment: 45
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • All: Participants 8-17 years of age
  • FD arms: Patients identified in CMH/Abdominal Pain Team Clinic with Functional Dyspepsia who meet exclusion criteria.
  • Control arm: healthy participants who meet exclusion criteria.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591174

Contacts
Contact: Nancy E. Lathrom 816/855/1860 nelathrom@cmh.edu
Contact: Shawna Ricks, RN, MSN 816/234/3197 sricks@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Nancy E. Lathrom    816-855-1860    nelathrom@cmh.edu   
Contact: Shawna Ricks, MSN, CRC    816/234/3197    sricks@cmh.edu   
Sub-Investigator: Craig A. Friesen, MD         
Sub-Investigator: Li Ding, PhD         
Sub-Investigator: Susan Abdel-Rahman, MD         
Sub-Investigator: Robin Pearce, MD         
Sub-Investigator: Jennifer V. Schurman, PhD         
Sub-Investigator: Nancy E. Lathrom         
Sub-Investigator: Shawna Ricks, RN, MSN         
Sub-Investigator: Corey Schurman, MA         
Sub-Investigator: Rachel Hasenkamp, RN, BSN         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Nadia M Hijaz, MD Fellow, Children's Mercy Hospital, Section of Gastroenterology
  More Information

Publications:
Akamizu T, Iwakura H, Ariyasu H, et al. Ghrelin and functional dyspepsia. International J of Peptides. 2010. Article ID: 548457.

Responsible Party: Nadia Hijaz, MD, Fellow, Children's Mercy Hospital, Section of Gastroenterology, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01591174     History of Changes
Other Study ID Numbers: Ghrelin 12010078
Study First Received: May 2, 2012
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Functional Dyspepsia
Postprandial Distress Syndrome
ghrelin
C-13 acetate

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 20, 2014