Effect of Menstrual Cycle on CNS Processing of Gut Stimuli in IBS and Control

This study has been terminated.
(inadequate number of patients, study completed with normal subjects)
Sponsor:
Collaborators:
American College of Gastroenterology
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00219531
First received: September 14, 2005
Last updated: June 1, 2011
Last verified: September 2009
  Purpose

The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of this signal. We also hypothesize that there is a difference in perception between control subjects and subjects with the irritable bowel syndrome.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: perception of rectal balloon distention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli

Resource links provided by NLM:


Further study details as provided by Penn State University:

Estimated Enrollment: 50
Study Start Date: March 1999
Groups/Cohorts Assigned Interventions
control
subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle.
Behavioral: perception of rectal balloon distention
fMRI study with measurement of brain MRI response to rectal balloon distention.
IBS
women with IBS symptoms and normal menstrual cycle.
Behavioral: perception of rectal balloon distention
fMRI study with measurement of brain MRI response to rectal balloon distention.

Detailed Description:

There is discrepancy in the literature concerning the effect of the menstrual cycle on bowel function and pain syndromes such at irritable bowel syndrome. In addition, recent studies indicate a difference in the CNS processing of rectal stimulation in normal subjects and patients with IBS. This study will determine the differences in the perception of rectal balloon distention in the follicular and luteal phases of the menstrual cycle, in control subjects with no bowel symptoms and volunteers with IBS, and will compare the CNS processing of this signal using functional MRI , again in the two phases of the menstrual cycle.

Comparisons: between control subjects without GI symptoms and those with irritable bowel syndrome.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with menstrual cycle

Criteria

Inclusion Criteria:

  • controls - normal bowel function
  • Irritable bowel syndrome - Rome II criteria
  • Normal menstrual cycle

Exclusion Criteria:

  • irregular menses
  • pregnancy
  • use of psychotropic medication
  • claustrophobia
  • metal implants
  • metal in eyes
  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: NCT00219531

Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
American College of Gastroenterology
Investigators
Principal Investigator: Ann Ouyang, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Deputy director, ACG Institute for Clinical Research and Education
ClinicalTrials.gov Identifier: NCT00219531     History of Changes
Other Study ID Numbers: 99-073, NIDDK R21 DK57053, ACG (no number)
Study First Received: September 14, 2005
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
functional MRI
pain perception
anxiety
brain-gut axis

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014