Irritable Bowel SyndromeNCT02566629
Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase
An observational study of Irritable Bowel Syndrome, run by Shandong University at 1 site in China.
Trial summary
Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- collect faeces from participants
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Nov 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who fulfil the Rome III criteria of irritable bowel syndrome in Qilu Hospital outpatient
Who may be able to join
- the presence of Rome III criteria for IBS ;
- Patients scheduled for colonoscopy examination or having negative screening examinations
- Aged between 18 and 65 years old
Who cannot join
- Antibiotic, probiotic or laxative usage within 4 weeks.
- organic gastrointestinal diseases
- Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- pregnancy or lactation.
- previous major or complicated abdominal surgery.
- severe endometriosis and dementia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD.PHD, 86-531-8216923 ext. 86-531-8216923, liyanqing@sdu.edu.cn
Jiaxin Du, MD
About this study
Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase.
Read the detailed description
The pathophysiology of IBS is incompletely understood, it may involve an altered intestinal microbiota. Since the microflora composition of IBS is various in different studies, The investigators plan to compare the intestinal microbiota of IBS patients in episodes phase and remission phase with healthy controls,trying to find the difference.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- collect faeces from participants
- Keywords
- microbiota community, IBS
- 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.
collect faeces from participantsOther
analyze the fecal microbiota community using 16S rDNA detection technique
| Study group | Role | What they receive |
|---|---|---|
| IBS patients in episodes phase | collect faeces from IBS patients in episodes remission phase Receives: Other: collect faeces from participants | |
| IBS patients in remission phase | collect faeces from IBS patients in remission phase Receives: Other: collect faeces from participants | |
| healthy controls | collect faeces from healthy controls Receives: Other: collect faeces from participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota community among IBS patients in episodes phase,remission phase and healthy controls
Measured: 5 months
Secondary outcomes (1)
quality of life in IBS patients
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD.PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566629
- Sponsor's protocol ID
- 2015SDU-QILU-G11
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase
- ClinicalTrials.gov ID
- NCT02566629
- Acronym / sponsor ID
- 2015SDU-QILU-G11
- Conditions
- Irritable Bowel Syndrome
- Keywords
- microbiota community, IBS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 2 Oct 2015 (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.
Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase.
Detailed description
The pathophysiology of IBS is incompletely understood, it may involve an altered intestinal microbiota. Since the microflora composition of IBS is various in different studies, The investigators plan to compare the intestinal microbiota of IBS patients in episodes phase and remission phase with healthy controls,trying to find the difference.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBS patients in episodes phase | – | Other: collect faeces from participantscollect faeces from IBS patients in episodes remission phase |
| IBS patients in remission phase | – | Other: collect faeces from participantscollect faeces from IBS patients in remission phase |
| healthy controls | – | Other: collect faeces from participantscollect faeces from healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who fulfil the Rome III criteria of irritable bowel syndrome in Qilu Hospital outpatient
Key inclusion criteria (3 listed)
- the presence of Rome III criteria for IBS ;
- Patients scheduled for colonoscopy examination or having negative screening examinations
- Aged between 18 and 65 years old
Key exclusion criteria (6 listed)
- Antibiotic, probiotic or laxative usage within 4 weeks.
- organic gastrointestinal diseases
- Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- pregnancy or lactation.
- previous major or complicated abdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collect faeces from participantsanalyze the fecal microbiota community using 16S rDNA detection technique | Other | IBS patients in episodes phase, IBS patients in remission phase, healthy controls |
Primary outcome
microbiota community among IBS patients in episodes phase,remission phase and healthy controls
Time frame: 5 months
1 secondary outcome
quality of life in IBS patients
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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, MD.PhD principal investigator
Qilu Hospital of Shandong University
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 Shandong University at 1 site in China.
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 6 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 2 Oct 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 China. 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 Yanqing Li, MD.PhD (86-531-82169236 ext. 86-531-8216923, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota community among IBS patients in episodes phase,remission phase and healthy controls (time frame: 5 months). It is what the study was designed to measure, not a finding.
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 2 Oct 2015.