Mucosa Associated Bacteria in Small IntestineNCT01679730
Changes of Microbiota in Irritable Bowel Syndrome Patients
An observational study of Mucosa Associated Bacteria in Small Intestine, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosa Associated Bacteria in Small Intestine
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Apr 2016
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Irritable bowel syndrome patients
Who may be able to join
- Case group: 20 to 80 years old irritable bowel syndrome patients
- Control group: 20 to 80 years old healthy subjects
Who cannot join
- without writtent informed consent
- contraindications for enteroscopy
Trial locations and contacts
1 site in 1 country.
Chen-Shuan Chung, MD, M.Sc contact
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City
Chen-Shuan Chung, MD, M.Sc, chugnchenshuan_3@yahoo.com.tw
About this study
To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in component of microbiota between cases and controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2016 (estimated)
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 Mucosa Associated Bacteria in Small IntestineStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679730
- Sponsor's protocol ID
- FEMH-100126-F
- Status last verified
- Sep 2012
- First submitted
- 21 Aug 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung CS, Chang PF, Liao CH, Lee TH, Chen Y, Lee YC, Wu MS, Wang HP, Ni YH. Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects. Scand J Gastroenterol. 2016;51(4):410-9. doi: 10.3109/00365521.2015.1116107. Epub 2015 Nov 23.
PubMed 26595305
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Microbiota in Irritable Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT01679730
- Acronym / sponsor ID
- FEMH-100126-F
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2016 (estimated)
- First posted
- 6 Sep 2012 (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 investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irritable bowel syndrome patients | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Irritable bowel syndrome patients
Key inclusion criteria (2 listed)
- Case group: 20 to 80 years old irritable bowel syndrome patients
- Control group: 20 to 80 years old healthy subjects
Key exclusion criteria (2 listed)
- without writtent informed consent
- contraindications for enteroscopy
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
difference in component of microbiota between cases and controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 26595305Chung CS, Chang PF, Liao CH, Lee TH, Chen Y, Lee YC, Wu MS, Wang HP, Ni YH. Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects. Scand J Gastroenterol. 2016;51(4):410-9. doi: 10.3109/00365521.2015.1116107. Epub 2015 Nov 23.
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.
Chen-Shuan Chung, MD, M.Sc contact
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 Mucosa Associated Bacteria in Small Intestine, run by Far Eastern 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 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: status not confirmed, as of the sponsor's last update on 10 Mar 2015. 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?
Contact Chen-Shuan Chung, MD, M.Sc (chungchenshuan_3@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in component of microbiota between cases and controls. 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 NCT01679730, 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 10 Mar 2015.