Irritable Bowel SyndromeNCT00219531
Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control
An observational study of Irritable Bowel Syndrome, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- perception of rectal balloon distention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with menstrual cycle
Who may be able to join
- controls - normal bowel function
- Irritable bowel syndrome - Rome II criteria
- Normal menstrual cycle
Who cannot join
- irregular menses
- pregnancy
- use of psychotropic medication
- claustrophobia
- metal implants
- metal in eyes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- perception of rectal balloon distention
- Keywords
- functional MRI, pain perception, anxiety, brain-gut axis
- Medical subject headings
- Irritable Bowel Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perception of rectal balloon distentionBehavioural
functional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.
| Study group | Role | What they receive |
|---|---|---|
| control | subjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle. Receives: Behavioral: perception of rectal balloon distention | |
| IBS | women with IBS symptoms and normal menstrual cycle. Receives: Behavioral: perception of rectal balloon distention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the study period only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 1999
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: inadequate number of patients, study completed with normal subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- Ann Ouyang, MD, Principal investigator, Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219531
- Sponsor's protocol ID
- 99-073
- Other IDs
- NIDDK R21 DK57053, ACG Research Award 2000-2001
- Status last verified
- Nov 2017
- First submitted
- 14 Sep 2005
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli
- ClinicalTrials.gov ID
- NCT00219531
- Acronym / sponsor ID
- 99-073
- Conditions
- Irritable Bowel Syndrome
- Keywords
- functional MRI, pain perception, anxiety, brain-gut axis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inadequate number of patients, study completed with normal subjects
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American College of Gastroenterology
- Study start
- Mar 1999
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Behavioral: perception of rectal balloon distentionsubjects with no irritable bowel syndrome or gastrointestinal complaints and regular menstrual cycle. |
| IBS | – | Behavioral: perception of rectal balloon distentionwomen with IBS symptoms and normal menstrual cycle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with menstrual cycle
Key inclusion criteria (3 listed)
- controls - normal bowel function
- Irritable bowel syndrome - Rome II criteria
- Normal menstrual cycle
Key exclusion criteria (6 listed)
- irregular menses
- pregnancy
- use of psychotropic medication
- claustrophobia
- metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perception of rectal balloon distentionfunctional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention. | Behavioural | IBS, control |
Primary outcome
Sensitivity to rectal distention
Time frame: 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
Results and safety
The study was stopped early (reason given: inadequate number of patients, study completed with normal subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- BackgroundWrzos 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
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Ouyang, MD principal investigator
Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inadequate number of patients, study completed with normal subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity to rectal distention (time frame: during the study period only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00219531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.