Effect of Clostridium Butyricum in Treating Irritable Bowel SyndromePhase 4NCT02614963
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
A Phase 4 study testing Clostridium Butyricum in people with Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome, run by Shandong University at 1 site in China.
Trial summary
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
- What is being tested?
- Clostridium Butyricum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jul 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of Rome III criteria for IBS ;
- 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, 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
Official title: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome
- Being tested
- Clostridium Butyricum, placebo
- Keywords
- Irritable Bowel Syndrome, Clostridium Butyricum
- 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.
Clostridium ButyricumDrug
Irritable bowel syndrome patients treated with Clostridium Butyricum
placeboDrug
Irritable bowel syndrome patients treated with placebo
| Study group | Role | What they receive |
|---|---|---|
| Clostridium Butyricum group | Experimental | Irritable bowel syndrome patients treated with Clostridium Butyricum Receives: Drug: Clostridium Butyricum |
| Placebo group | Placebo comparator | Irritable bowel syndrome patients treated with placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
Measured: 7 months
Secondary outcomes (2)
IBS patients'quality of life
Quality of life was determined by using IBS-QOL scoring system for patients with IBS.
Measured: 7 months
Composition of Microorganisms in stool
Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Clostridium Butyricum in Treating 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Linyi People's Hospital, Taian City Central Hospital, Qingdao Eastsea Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614963
- Sponsor's protocol ID
- 2015SDU-QILU-G13
- Status last verified
- Mar 2016
- First submitted
- 23 Nov 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT02614963
- Acronym / sponsor ID
- 2015SDU-QILU-G13
- Keywords
- Irritable Bowel Syndrome, Clostridium Butyricum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Linyi People's Hospital, Taian City Central Hospital, Qingdao Eastsea Pharmaceutical Co., Ltd.
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 25 Nov 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.
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clostridium Butyricum group | Experimental | Drug: Clostridium ButyricumIrritable bowel syndrome patients treated with Clostridium Butyricum |
| Placebo group | Placebo comparator | Drug: placeboIrritable bowel syndrome patients treated with placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of Rome III criteria for IBS ;
- 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 |
|---|---|---|
| Clostridium ButyricumIrritable bowel syndrome patients treated with Clostridium Butyricum | Drug | Clostridium Butyricum group |
| placeboIrritable bowel syndrome patients treated with placebo | Drug | Placebo group |
Primary outcome
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
Time frame: 7 months
2 secondary outcomes
IBS patients'quality of life
Time frame: 7 months
Composition of Microorganisms in stool
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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.
Li Yanqing, 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?
A Phase 4 study testing Clostridium Butyricum in people with Effect of Clostridium Butyricum in Treating 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 2 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 17 May 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li Yanqing, MD,PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores (time frame: 7 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 17 May 2016.