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Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control

This study has been terminated.
(inadequate number of patients, study completed with normal subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219531
First Posted: September 22, 2005
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American College of Gastroenterology
Information provided by (Responsible Party):
Penn State University
  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:

Primary Outcome Measures:
  • Sensitivity to rectal distention [ Time Frame: during the study period only ]
    pressure at which certain sensations are felt when barostat is inflated in the rectum during follicular and luteal phase of menstrual cycle


Enrollment: 48
Study Start Date: March 1999
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control
subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle.
Behavioral: perception of rectal balloon distention
functional Magnetic Resonance Imaging (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
functional Magnetic Resonance Imaging (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219531


Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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

Publications:
Wrzos HF, Li Q, Ouyang A. Visceral and somatic pain thresholds in healthy and IBS volunteers across the menstrual cycle. The American Journal of Gastroenterology 98: S265, 2003

Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00219531     History of Changes
Other Study ID Numbers: 99-073
NIDDK R21 DK57053
ACG Research Award 2000-2001
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: November 29, 2017
Last Verified: November 2017

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

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