Irritable Bowel SyndromefMRINCT00677976
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.
Who may be able to join
- Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation
- English-speaking
- Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.
Who cannot join
- Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder
- Mental retardation or pervasive developmental disorder or epilepsy
- Psychosis
- Genetic or chromosomal disorders
- Currently receiving psychoactive drug treatment
- Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning
Show all 11Show fewer
- Inability to lie still in the scanner
- Claustrophobia (Inability to lie still in the scanner)
- Pregnancy
- Subjects who admit to substance abuse during screening
- Orthodontic braces
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.
Read the detailed description
Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- fMRI, IBS, Brain Activation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS | Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist. | |
| Control | Healthy children between the ages of 10 and 18. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We intend to measure the degree of brain activation following rectal stimulation
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manu Sood, Medical College of Wisconsin
- Investigators
- Manu Sood, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677976
- Sponsor's protocol ID
- CHW 06/163
- Acronym
- fMRI
- Status last verified
- Apr 2020
- First submitted
- 12 May 2008
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, Whitehead WE, Janssens J, Funch-Jensen P, Corazziari E, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993 Sep;38(9):1569-80. doi: 10.1007/BF01303162.
PubMed 8359066Talley NJ, Zinsmeister AR, Van Dyke C, Melton LJ 3rd. Epidemiology of colonic symptoms and the irritable bowel syndrome. Gastroenterology. 1991 Oct;101(4):927-34. doi: 10.1016/0016-5085(91)90717-y.
PubMed 1889716Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
PubMed 16678566Hyams JS, Burke G, Davis PM, Rzepski B, Andrulonis PA. Abdominal pain and irritable bowel syndrome in adolescents: a community-based study. J Pediatr. 1996 Aug;129(2):220-6. doi: 10.1016/s0022-3476(96)70246-9.
PubMed 8765619Hyams JS, Treem WR, Justinich CJ, Davis P, Shoup M, Burke G. Characterization of symptoms in children with recurrent abdominal pain: resemblance to irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 1995 Feb;20(2):209-14. doi: 10.1097/00005176-199502000-00012.
PubMed 7714688Walker LS, Lipani TA, Greene JW, Caines K, Stutts J, Polk DB, Caplan A, Rasquin-Weber A. Recurrent abdominal pain: symptom subtypes based on the Rome II Criteria for pediatric functional gastrointestinal disorders. J Pediatr Gastroenterol Nutr. 2004 Feb;38(2):187-91. doi: 10.1097/00005176-200402000-00016.
PubMed 14734882Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
PubMed 1826329Van Ginkel R, Voskuijl WP, Benninga MA, Taminiau JA, Boeckxstaens GE. Alterations in rectal sensitivity and motility in childhood irritable bowel syndrome. Gastroenterology. 2001 Jan;120(1):31-8. doi: 10.1053/gast.2001.20898.
PubMed 11208711Di Lorenzo C, Youssef NN, Sigurdsson L, Scharff L, Griffiths J, Wald A. Visceral hyperalgesia in children with functional abdominal pain. J Pediatr. 2001 Dec;139(6):838-43. doi: 10.1067/mpd.2001.118883.
PubMed 11743510Hobson AR, Aziz Q. Brain imaging and functional gastrointestinal disorders: has it helped our understanding? Gut. 2004 Aug;53(8):1198-206. doi: 10.1136/gut.2003.035642. No abstract available.
PubMed 15247191Aziz Q, Andersson JL, Valind S, Sundin A, Hamdy S, Jones AK, Foster ER, Langstrom B, Thompson DG. Identification of human brain loci processing esophageal sensation using positron emission tomography. Gastroenterology. 1997 Jul;113(1):50-9. doi: 10.1016/s0016-5085(97)70079-9.
PubMed 9207261Schnitzler A, Ploner M. Neurophysiology and functional neuroanatomy of pain perception. J Clin Neurophysiol. 2000 Nov;17(6):592-603. doi: 10.1097/00004691-200011000-00005.
PubMed 11151977Willis WD, Westlund KN. Neuroanatomy of the pain system and of the pathways that modulate pain. J Clin Neurophysiol. 1997 Jan;14(1):2-31. doi: 10.1097/00004691-199701000-00002.
PubMed 9013357Wilder-Smith CH, Schindler D, Lovblad K, Redmond SM, Nirkko A. Brain functional magnetic resonance imaging of rectal pain and activation of endogenous inhibitory mechanisms in irritable bowel syndrome patient subgroups and healthy controls. Gut. 2004 Nov;53(11):1595-601. doi: 10.1136/gut.2003.028514.
PubMed 15479679Sidhu H, Kern M, Shaker R. Absence of increasing cortical fMRI activity volume in response to increasing visceral stimulation in IBS patients. Am J Physiol Gastrointest Liver Physiol. 2004 Aug;287(2):G425-35. doi: 10.1152/ajpgi.00490.2003.
PubMed 15246969
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00677976
- Acronym / sponsor ID
- fMRI / CHW 06/163
- Conditions
- Irritable Bowel Syndrome
- Keywords
- fMRI, IBS, Brain Activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 May 2008 (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 purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.
Detailed description
Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS | – | –Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist. |
| Control | – | –Healthy children between the ages of 10 and 18. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.
Key inclusion criteria (3 listed)
- Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation
- English-speaking
- Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.
Key exclusion criteria (11 listed)
- Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder
- Mental retardation or pervasive developmental disorder or epilepsy
- Psychosis
- Genetic or chromosomal disorders
- Currently receiving psychoactive drug treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We intend to measure the degree of brain activation following rectal stimulation
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Background: PubMed 8359066Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, Whitehead WE, Janssens J, Funch-Jensen P, Corazziari E, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993 Sep;38(9):1569-80. doi: 10.1007/BF01303162.
- Background: PubMed 1889716Talley NJ, Zinsmeister AR, Van Dyke C, Melton LJ 3rd. Epidemiology of colonic symptoms and the irritable bowel syndrome. Gastroenterology. 1991 Oct;101(4):927-34. doi: 10.1016/0016-5085(91)90717-y.
- Background: PubMed 16678566Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
- Background: PubMed 8765619Hyams JS, Burke G, Davis PM, Rzepski B, Andrulonis PA. Abdominal pain and irritable bowel syndrome in adolescents: a community-based study. J Pediatr. 1996 Aug;129(2):220-6. doi: 10.1016/s0022-3476(96)70246-9.
- Background: PubMed 7714688Hyams JS, Treem WR, Justinich CJ, Davis P, Shoup M, Burke G. Characterization of symptoms in children with recurrent abdominal pain: resemblance to irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 1995 Feb;20(2):209-14. doi: 10.1097/00005176-199502000-00012.
- Background: PubMed 14734882Walker LS, Lipani TA, Greene JW, Caines K, Stutts J, Polk DB, Caplan A, Rasquin-Weber A. Recurrent abdominal pain: symptom subtypes based on the Rome II Criteria for pediatric functional gastrointestinal disorders. J Pediatr Gastroenterol Nutr. 2004 Feb;38(2):187-91. doi: 10.1097/00005176-200402000-00016.
- Background: PubMed 1826329Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
- Background: PubMed 11208711Van Ginkel R, Voskuijl WP, Benninga MA, Taminiau JA, Boeckxstaens GE. Alterations in rectal sensitivity and motility in childhood irritable bowel syndrome. Gastroenterology. 2001 Jan;120(1):31-8. doi: 10.1053/gast.2001.20898.
- Background: PubMed 11743510Di Lorenzo C, Youssef NN, Sigurdsson L, Scharff L, Griffiths J, Wald A. Visceral hyperalgesia in children with functional abdominal pain. J Pediatr. 2001 Dec;139(6):838-43. doi: 10.1067/mpd.2001.118883.
- Background: PubMed 15247191Hobson AR, Aziz Q. Brain imaging and functional gastrointestinal disorders: has it helped our understanding? Gut. 2004 Aug;53(8):1198-206. doi: 10.1136/gut.2003.035642. No abstract available.
- Background: PubMed 9207261Aziz Q, Andersson JL, Valind S, Sundin A, Hamdy S, Jones AK, Foster ER, Langstrom B, Thompson DG. Identification of human brain loci processing esophageal sensation using positron emission tomography. Gastroenterology. 1997 Jul;113(1):50-9. doi: 10.1016/s0016-5085(97)70079-9.
- Background: PubMed 11151977Schnitzler A, Ploner M. Neurophysiology and functional neuroanatomy of pain perception. J Clin Neurophysiol. 2000 Nov;17(6):592-603. doi: 10.1097/00004691-200011000-00005.
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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.
Manu Sood, MD principal investigator
Medical College of Wisconsin
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 Medical College of Wisconsin 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 11 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: finished, as of the sponsor's last update on 30 Apr 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
We intend to measure the degree of brain activation following rectal stimulation (time frame: 4 years). 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 NCT00677976, which also lists 47 linked publications.
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 30 Apr 2020.