Irritable Bowel SyndromeNCT00925223
Brain-derived Neurotrophic Factor Participates in Visceral Hyperalgesia in Irritable Bowel Syndrome (IBS) Patients
An observational study of Irritable Bowel Syndrome, run by Shandong University.
Trial summary
Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Nov 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits in the absence of structural and biochemical abnormalities.
Who may be able to join
- Patients diagnosed with irritable bowel syndrome.
Who cannot join
- Patients have similar clinical symptoms as IBS, yet there is morphologic changes in the intestine.
About this study
Official title: Study of Brain-derived Neurotrophic Factor in Visceral Hyperalgesia in IBS Patients
Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS patients.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, BDNf, visceral hypersensitivity
- 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 |
|---|---|---|
| irritable bowel syndrome | patients with diarrhea-predominant IBS will be enrolled in this group. | |
| control group | patients with colon cancer or colon polyp will be enrolled as control group. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009 (estimated)
- Study completionNov 2009 (estimated)
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.
- 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
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Investigators
- Yanqing Li, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925223
- Sponsor's protocol ID
- 2009SDU-QILU-G02
- Other IDs
- NSFC30570831
- Status last verified
- Oct 2009
- First submitted
- 18 Jun 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain-derived Neurotrophic Factor in Visceral Hyperalgesia in IBS Patients
- ClinicalTrials.gov ID
- NCT00925223
- Acronym / sponsor ID
- 2009SDU-QILU-G02
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, BDNf, visceral hypersensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 22 Jun 2009 (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.
Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS patients.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irritable bowel syndrome | – | –patients with diarrhea-predominant IBS will be enrolled in this group. |
| control group | – | –patients with colon cancer or colon polyp will be enrolled as control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits in the absence of structural and biochemical abnormalities.
Key inclusion criteria (1 listed)
- Patients diagnosed with irritable bowel syndrome.
Key exclusion criteria (1 listed)
- Patients have similar clinical symptoms as IBS, yet there is morphologic changes in the intestine.
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 14 Oct 2009.
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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.
Yanqing Li, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Shandong University.
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 1 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 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
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 14 Oct 2009.