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

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: perception of rectal balloon distention

• Registration Number: NCT00219531
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	perception of rectal balloon distention	subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle.
IBS	perception of rectal balloon distention	women with IBS symptoms and normal menstrual cycle.

Primary Outcome Measures

Name	Time	Method
Sensitivity to rectal distention	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

Trial Locations

Locations (1)

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States