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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00219531

Enrollment

Registered

2005-09-22

Start date

1999-03-31

Completion date

2015-02-28

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

functional MRI, pain perception, anxiety, brain-gut axis

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.

Interventions

BEHAVIORALperception of rectal balloon distention

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026