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

NCT ID: NCT00219531

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

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Irritable Bowel Syndrome

Keywords

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functional MRI pain perception anxiety brain-gut axis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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control

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

perception of rectal balloon distention

Intervention Type BEHAVIORAL

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

IBS

women with IBS symptoms and normal menstrual cycle.

perception of rectal balloon distention

Intervention Type BEHAVIORAL

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

Interventions

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perception of rectal balloon distention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

American College of Gastroenterology

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Ouyang, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

Locations

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Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Wrzos HF, Li Q, Ouyang A. Visceral and somatic pain thresholds in healthy and IBS volunteers across the menstrual cycle. The American Journal of Gastroenterology 98: S265, 2003

Reference Type BACKGROUND

Other Identifiers

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NIDDK R21 DK57053

Identifier Type: -

Identifier Source: secondary_id

ACG Research Award 2000-2001

Identifier Type: -

Identifier Source: secondary_id

99-073

Identifier Type: -

Identifier Source: org_study_id