Trial record 10 of 48 for:    Open Studies | "Dyspepsia"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01373372
First received: June 13, 2011
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.

Condition Intervention
Functional Dyspepsia
Drug: Acthrel

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: CRH Responsiveness in Children With Functional Dyspepsia: A Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: Over 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stress profile [ Time Frame: over 90 minutes ] [ Designated as safety issue: No ]
    Surface Electromyograph readings, peripheral skin temperature readings, electrodermal response

  • plasma protein levels [ Time Frame: change over 60 minutes ] [ Designated as safety issue: No ]
    TNF-α, IL-4, IL-5, IL-8, eotaxin-3, MCP-1, MMP-9, ECP, MBP, cortisol, ACTH and CBG levels to be obtained at time of CRH infusion and 15, 30, 45 and 60 minutes after CRH infusion

  • BASC 2 profile [ Time Frame: change over 90 minutes ] [ Designated as safety issue: No ]
    To be given 30 minutes prior to CRH infusion and 15, 30 and 60 minutes after CRH infusion

  • STICSA-C [ Time Frame: change over 90 minutes ] [ Designated as safety issue: No ]
    To be given 30 minutes prior to CRH infusion and 15, 30 and 60 minutes after CRH infusion.

  • GI symptom severity scale [ Time Frame: change over 90 minutes ] [ Designated as safety issue: No ]
    To be given 30 minutes prior to CRH infusion and 15, 30 and 60 minutes after CRH infusion.


Estimated Enrollment: 24
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Dyspepsia cohort
Cohort of subjects with functional dyspepsia
Drug: Acthrel
Powder for reconstitution, 1.0 mcg/kg body weight to a maximum of 100 mcg, delivered one time via IV over one minute.
Other Name: Corticorelin
Control cohort
Control group of subjects with no functional dyspepsia
Drug: Acthrel
Powder for reconstitution, 1.0 mcg/kg body weight to a maximum of 100 mcg, delivered one time via IV over one minute.
Other Name: Corticorelin

  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373372

Contacts
Contact: Nancy Lathrom 816-234-1860 nelathrom@cmh.edu
Contact: Corey Schurman, MA 816-802-1167 crschurman@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital and Clinics Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: Nancy Lathrom    816-234-1860    nelathrom@cmh.edu   
Contact: Corey Schurman, MA    816-802-1167    crschurman@cmh.edu   
Principal Investigator: Craig Friesen, MD         
Sub-Investigator: Susan Abdel-Rahman, PharmD         
Sub-Investigator: Jennifer V Schurman, PhD         
Sub-Investigator: Marcia Chan, PhD         
Sub-Investigator: Amanda Drews, PhD         
Sub-Investigator: Ghufran Babar, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Craig A Friesen, MD Children's Mercy Hospital and Clinics
  More Information

No publications provided

Responsible Party: Craig Friesen, MD, Children's Mercy Hospital and Clinics
ClinicalTrials.gov Identifier: NCT01373372     History of Changes
Other Study ID Numbers: 11 05-069
Study First Received: June 13, 2011
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
functional dyspepsia
GI

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Corticotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014