Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia

NCT01373372 | Withdrawn

• 1 other identifier: 11 05-069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Dyspepsia

Keywords

functional dyspepsia; GI

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Over 90 minutes

Secondary Outcomes (5)

• Stress profile

  over 90 minutes

• plasma protein levels

  change over 60 minutes

• BASC 2 profile

  change over 90 minutes

• STICSA-C

  change over 90 minutes

• GI symptom severity scale

  change over 90 minutes

Study Arms (2)

Functional Dyspepsia cohort

EXPERIMENTAL

Cohort of subjects with functional dyspepsia

Drug: Acthrel

Control cohort

OTHER

Control group of subjects with no functional dyspepsia

Drug: Acthrel

Interventions

Acthrel DRUG

Powder for reconstitution, 1.0 mcg/kg body weight to a maximum of 100 mcg, delivered one time via IV over one minute.

Also known as: Corticorelin

Control cohort; Functional Dyspepsia cohort

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

corticorelin ovine; Corticotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Craig A Friesen, MD

  Children's Mercy Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (1)