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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219531
• Other study ID #: 99-073
• Secondary ID: NIDDK R21 DK5705
• Status: Terminated
• Phase: N/A
• First received: September 14, 2005
• Last updated: November 28, 2017
• Start date: March 1999
• Est. completion date: February 2015

Study information

• Verified date: November 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity to rectal distention	pressure at which certain sensations are felt when barostat is inflated in the rectum during follicular and luteal phase of menstrual cycle	during the study period only