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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: perception of rectal balloon distention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle. | Behavioral: perception of rectal balloon distention<br>* functional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.<br>|
| IBS<br>women with IBS symptoms and normal menstrual cycle. | Behavioral: perception of rectal balloon distention<br>* functional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity to rectal distention | pressure at which certain sensations are felt when barostat is inflated in the rectum during follicular and luteal phase of menstrual cycle | during the study period only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional MRI, pain perception, anxiety, brain-gut axis