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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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes

September 14, 2005
June 1, 2011
March 1999
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Complete list of historical versions of study NCT00219531 on ClinicalTrials.gov Archive Site
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Effect of Menstrual Cycle on CNS Processing of Gut Stimuli in IBS and Control
Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

women with menstrual cycle
Irritable Bowel Syndrome
Behavioral: perception of rectal balloon distention
fMRI study with measurement of brain MRI response to rectal balloon distention.
  • control
    subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle.
    Intervention: Behavioral: perception of rectal balloon distention
  • IBS
    women with IBS symptoms and normal menstrual cycle.
    Intervention: Behavioral: perception of rectal balloon distention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
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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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219531
99-073, NIDDK R21 DK57053, ACG (no number)
No
Deputy director, ACG Institute for Clinical Research and Education
Penn State University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • American College of Gastroenterology
Principal Investigator: Ann Ouyang, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
Penn State University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP