Irritable Bowel SyndromeNCT01099787
Pediatric Alliance for International Neurogastrointestinal Functional Research
An observational study of Irritable Bowel Syndrome, run by Nationwide Children's Hospital at 7 sites in 2 countries.
Trial summary
To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children. To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 348 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2010to Jun 2017
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients ages 4 through 16 years of age (up to the day of the 17th birthday) will be recruited from the Nationwide Children's Hospital Gastrointestinal Department that are presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months.
Who may be able to join
- Males and females ages 4 through 16 years of age (up to the day of the 17th birthday)
- Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry.
Who cannot join
- Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled.
- Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Childrens Memorial Hospital
Chicago, Illinois, 60614
Nationwide Children's Hospital
Columbus, Ohio, 43205
Connecticut Children's Hospital
Hartford, Connecticut, 06106
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
LSU Health Sciences Center
New Orleans, Louisiana, 70118
About this study
Official title: Pediatric Alliance for International Neurogastrointestinal Functional Research Registry
To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children.
To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients.
Read more
To document the benefit of various treatment regimens currently employed in managing FGID.
To assess the short- and long-term impact of various FGID regimens.
To allow physicians to gain a better understanding of the epidemiology of FGID.
Hypothesis:
There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS.
Symptoms of children with FAP/IBS change overtime regardless of the treatments used.
- Conditions
- Irritable Bowel Syndrome
- 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 |
|---|---|---|
| FAP IBS | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Di Lorenzo, Nationwide Children's Hospital
- Investigators
- Carlo Di Lorenzo, M.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099787
- Sponsor's protocol ID
- IRB10-00022
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2010
- Last updated
- 19 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Alliance for International Neurogastrointestinal Functional Research Registry
- ClinicalTrials.gov ID
- NCT01099787
- Acronym / sponsor ID
- IRB10-00022
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Apr 2010 (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.
To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children.
To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients.
To document the benefit of various treatment regimens currently employed in managing FGID.
To assess the short- and long-term impact of various FGID regimens.
To allow physicians to gain a better understanding of the epidemiology of FGID.
Hypothesis:
There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS.
Symptoms of children with FAP/IBS change overtime regardless of the treatments used.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAP IBS | – | – |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients ages 4 through 16 years of age (up to the day of the 17th birthday) will be recruited from the Nationwide Children's Hospital Gastrointestinal Department that are presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months.
Key inclusion criteria (2 listed)
- Males and females ages 4 through 16 years of age (up to the day of the 17th birthday)
- Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry.
Key exclusion criteria (2 listed)
- Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled.
- Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)
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
Not reported in the source record.
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 19 Jul 2018.
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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.
Carlo Di Lorenzo, M.D. principal investigator
Nationwide Children's Hospital
7 sites in 2 countries: 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 Nationwide Children's Hospital at 7 sites in 2 countries.
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 2 inclusion and 2 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Netherlands. 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.
Where can I read the original study information?
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 19 Jul 2018.