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

NCT00219531 | Terminated

• 3 other identifiers: 99-073NIDDK R21 DK57053ACG Research Award 2000-2001
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control

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

Behavioral: perception of rectal balloon distention

IBS

women with IBS symptoms and normal menstrual cycle.

Behavioral: perception of rectal balloon distention

Interventions

perception of rectal balloon distention BEHAVIORAL

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

IBS; control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women with menstrual cycle

You may qualify if:

• controls - normal bowel function
• Irritable bowel syndrome - Rome II criteria
• Normal menstrual cycle

You may not qualify if:

• irregular menses
• pregnancy
• use of psychotropic medication
• claustrophobia
• metal implants
• metal in eyes

Sponsors & Collaborators

• Penn State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• American College of Gastroenterology: collaborator

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related 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

  BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Anxiety Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Study Officials

• Ann Ouyang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 1999
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)