Irritable Bowel SyndromeNCT01131442
Immunological Change and the Single Nucleotide Polymorphism (SNP) in Children With Irritable Bowel Syndrome (IBS)
An observational study of Irritable Bowel Syndrome and Children, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Children
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2008to not given
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: out patient clinics in the hospital
Who may be able to join
- (5-18y/o) with IBS,
- All patients had chronic or relapsing symptoms of IBS consistent with the ROME II criteria
Who cannot join
- A history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memeorial Hospital
Keelung
Man-Chin Hua, M.D., 886-2-24313131 ext. 2626, menchinhua@gmail.com
Man-Chin Hua Hua, M.D.
About this study
Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder.Many children suffered from this disease and had impact on their daily life. However, the underlying pathophysiologic mechanisms remain to be elucidate. Dysregulation of the gut immune system is considered an important pathophysiology. We want to investigate the immunological changes in the IBS children.
- Conditions
- Irritable Bowel Syndrome, Children
- Keywords
- immune
- 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 |
|---|---|---|
| The patient group | Not described | |
| healthy control group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Chang Gung Memorial 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131442
- Sponsor's protocol ID
- CMRPG270371
- Status last verified
- May 2010
- First submitted
- 25 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
Publications
Hua MC, Chao HC, Yao TC, Lai MW, Huang JL; PATCH Study Group. Investigation of interleukin-10 promoter polymorphisms and interleukin-10 levels in children with irritable bowel syndrome. Gut Liver. 2013 Jul;7(4):430-6. doi: 10.5009/gnl.2013.7.4.430. Epub 2013 Jun 11.
PubMed 23898383Hua MC, Lai MW, Kuo ML, Yao TC, Huang JL, Chen SM. Decreased interleukin-10 secretion by peripheral blood mononuclear cells in children with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):376-81. doi: 10.1097/MPG.0b013e3181fd9816.
PubMed 21407110
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Change and the Single Nucleotide Polymorphism (SNP) in Children With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT01131442
- Acronym / sponsor ID
- CMRPG270371
- Conditions
- Irritable Bowel Syndrome, Children
- Keywords
- immune
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 27 May 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.
Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS.
Detailed description
Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder.Many children suffered from this disease and had impact on their daily life. However, the underlying pathophysiologic mechanisms remain to be elucidate. Dysregulation of the gut immune system is considered an important pathophysiology. We want to investigate the immunological changes in the IBS children.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patient group | – | – |
| healthy control group | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- out patient clinics in the hospital
Key inclusion criteria (2 listed)
- (5-18y/o) with IBS,
- All patients had chronic or relapsing symptoms of IBS consistent with the ROME II criteria
Key exclusion criteria (1 listed)
- A history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Derived from this study: PubMed 23898383Hua MC, Chao HC, Yao TC, Lai MW, Huang JL; PATCH Study Group. Investigation of interleukin-10 promoter polymorphisms and interleukin-10 levels in children with irritable bowel syndrome. Gut Liver. 2013 Jul;7(4):430-6. doi: 10.5009/gnl.2013.7.4.430. Epub 2013 Jun 11.
- Derived from this study: PubMed 21407110Hua MC, Lai MW, Kuo ML, Yao TC, Huang JL, Chen SM. Decreased interleukin-10 secretion by peripheral blood mononuclear cells in children with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):376-81. doi: 10.1097/MPG.0b013e3181fd9816.
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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.
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 and Children, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 27 May 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131442, which also lists 2 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 27 May 2010.