Clinical Trials Directory

Trials / Terminated

TerminatedNCT00219531

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
48 (actual)
Sponsor
Penn State University · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALperception of rectal balloon distentionfunctional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.

Timeline

Start date
1999-03-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2005-09-22
Last updated
2017-11-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00219531. Inclusion in this directory is not an endorsement.