Functional Dyspepsia | Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia
Functional Dyspepsia research study
What is the primary objective of this study?
Chronic abdominal pain is the most common persistent pain condition in children and adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the bathroom. For some people it appears that stress can make FD worse. In adults, stress can cause the release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can cause abdominal pain by affecting how fast things move through a person's stomach and intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness of the inside lining of the stomach and intestines. Different people react differently when the body releases CRH. Some people have abdominal pain without feeling any stress or anxiety while other people who have a lot of stress or anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or abdominal pain when CRH is released into the body. In order to see how the bodies of children with functional dyspepsia and those without functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test is routinely done in endocrine patients. It is not routinely done for patients with functional dyspepsia or for patients who do not have functional dyspepsia. Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel® (brand name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug Administration (FDA) for use. The purpose of this research study is to see if there are differences in how the bodies of children with functional dyspepsia react to CRH versus children who don't have functional dyspepsia. Being in this study involves one clinic visit where an IV placed and a CRH stimulation test. In this test the child will be given an injection of CRH and then observed for one hour. During that hour the child will have five blood draws through the IV and will be asked questions about their anxiety and abdominal pain. This visit will take about 4 hours. The following things will happen: - Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This means your child will have had nothing to eat or drink for 8 hours before coming to the clinic. - If your child is a female ten years of age or older, or has started having periods, a urine pregnancy test will be done before receiving the CRH infusion. - You and your child will each be asked to complete a survey that measures your child's anxiety. - Your child will have a biofeedback session that will measure your child's stress. In a biofeedback session, sensors are placed on your child's fingers, wrists and forehead. These sensors are connected to a computer that monitors your child's heartbeat, skin temperature and electrical pulses on your child's skin. - Your child will have an IV inserted into a vein in his/her arm. Your child may have a cream put on their arm to help with the pain of the IV insertion. The IV will be used to inject the CRH and draw blood. If the IV stops working and blood samples can no longer be drawn from it, your child may have another IV started or blood samples may be drawn by needle stick. - Your child will then have 30 minutes to relax. - Your child will then have CRH infused through the IV over one minute. - Your child will have blood drawn through the IV five times; right before the CRH stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total amount of blood drawn for the study will be about 2 ½ tablespoons. - Your child will be asked about their abdominal pain, nausea, bloating, stress and anxiety at three separate times during the 60 minutes. - Your child's heart rate will be measured throughout the CRH stimulation test.
Who is eligible to participate?
Inclusion Criteria: - Group 1 (functional dyspepsia): - Ages 8-17 inclusive; - Abdominal pain of at least 8 weeks duration and fulfilling symptom-base criteria for FD; - Scheduled for endoscopy to evaluate dyspepsia following non-response to standard acid reduction therapy; - >20kg/45 lbs. and, - Group 2 (Controls): - Ages 8-17 inclusive; - >20kg/45 lbs. Exclusion Criteria: - Both groups: - Previous abdominal surgery; - <20 kg/45 lbs.: - Pregnancy; - Chronic disease requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer); or, - Non-English speaking. - Controls: - Recent history (within 6 months) of abdominal pain, nausea, vomiting, diarrhea, constipation, or bloating based on parental and self-report.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ActhrelPowder for reconstitution, 1.0 mcg/kg body weight to a maximum of 100 mcg, delivered one time via IV over one minute.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Functional Dyspepsia cohortCohort of subjects with functional dyspepsia
Control cohortControl group of subjects with no functional dyspepsia
Start Date: December 2014
Completed Date: March 2017
Primary Outcome: Heart rate variability
Secondary Outcome: Stress profile
Study sponsors, principal investigator, and references
Principal Investigator: Craig A Friesen, MD
Lead Sponsor: Children's Mercy Hospital Kansas City