Effect of Menstrual Cycle on CNS Processing of Gut Stimuli in IBS and Control
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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 |
| 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 |
women with menstrual cycle
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| United States, Pennsylvania | |
| Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| 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 May 22, 2013