NCT00195975

Brief Summary

The current study is designed to assess relationships between anxiety/stress, autonomic nervous system balance, and electrical activity in the stomach before and after eating/drinking in children with abdominal pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

3.2 years

First QC Date

September 14, 2005

Last Update Submit

June 27, 2011

Conditions

Abdominal Pain

Keywords

Abdominal PainFunctional Gastrointestinal DisordersStressAnxietyAutonomic Nervous System

Outcome Measures

Primary Outcomes (4)

  • HRV or the magnitude of power in the LF or HF in the fasting or post-prandial state

    Same day

  • HRV or stress profile parameters following an acute stress(mental math)

    Same day

  • Frequency of an abnormal EGG or the magnitude of EGG parameters

    Same day

  • Water load volume

    Same day

Secondary Outcomes (3)

  • Behavioral Assessment System for Children (BASC)

    Same day

  • Salivary cortisol

    Same day

  • A stress profile via the biofeedback equipment (e.g. measures of muscle tension, hand temperature, and skin moisture (conductance).

    Same day

Study Arms (2)

1

Children with FD

4

Healthy controls

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.

You may qualify if:

  • Ages 8 - 17 years
  • Evaluated in Abdominal Pain Clinic at Children's Mercy Hospital or the Gastroenterology Clinic at Children's Mercy South for abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for FD, IBS, or FD/IBS.

You may not qualify if:

  • Previous abdominal surgery
  • Chronic disease requiring regular medical care (e.g. gastrointestinal diseases, diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer).
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Abdominal PainGastrointestinal DiseasesAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveDigestive System DiseasesMental Disorders

Study Officials

  • Jennifer V Schurman, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2008

Study Completion

March 1, 2009

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

US(1)