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

The Pennsylvania State University (PENNSTATE)

Status: Terminated

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: perception of rectal balloon distention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00219531

ACG Research Award 2000-2001

99-073

NIDDK R21 DK57053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

control

Description:

subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle.

Treatment:

Behavioral: perception of rectal balloon distention

IBS

Description:

women with IBS symptoms and normal menstrual cycle.

Treatment:

Behavioral: perception of rectal balloon distention