Irritable Bowel SyndromePBIBSNCT00737841
Effect of Bifidobacterium on Irritable Bowel Syndrome
A study testing Bifidobacterium breve in people with Irritable Bowel Syndrome, run by Tohoku University at 1 site in Japan.
Trial summary
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium breve
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2006to Sep 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBS with Rome II definition
Who cannot join
- Diagnosis of serious diseases (both physically and mentally)
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tohoku University Graduate School of Medicine
Sendai, Miyagi, 980-8575
Shin Fukudo, MD, PhD, +81-22-717-8214, sfukudo@mail.tains.tohoku.ac.jp
Machiko Watabe, +81-22-717-8162, wmachiko@mail.tains.tohoku.ac.jp
About this study
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.
Read the detailed description
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium breve, Placebo
- Keywords
- stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion
- 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.
Bifidobacterium breveDrug
1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
PlaceboDrug
1.0 g of placebo, taking orally, 3 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Bifidobacterium breve Receives: Drug: Bifidobacterium breve |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate relief and SIBSQ
Measured: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Secondary outcomes (1)
Psychometric test, bowel gas, blood, and feces.
Measured: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2008 (estimated)
- Study completionSep 2008 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tohoku University
- Sponsor type
- University, hospital or other
- Investigators
- Shin Fukudo, MD, PhD, Principal investigator, Tohoku University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737841
- Sponsor's protocol ID
- Probio-Bifid-IBS
- Acronym
- PBIBS
- Status last verified
- Aug 2008
- First submitted
- 18 Aug 2008
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium on Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00737841
- Acronym / sponsor ID
- PBIBS / Probio-Bifid-IBS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tohoku UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 20 Aug 2008 (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.
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.
Detailed description
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Bifidobacterium breveBifidobacterium breve |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of IBS with Rome II definition
Key exclusion criteria (1 listed)
- Diagnosis of serious diseases (both physically and mentally)
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 |
|---|---|---|
| Bifidobacterium breve1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks. | Drug | A |
| Placebo1.0 g of placebo, taking orally, 3 times a day for 8 weeks. | Drug | B |
Primary outcome
Adequate relief and SIBSQ
Time frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
1 secondary outcome
Psychometric test, bowel gas, blood, and feces.
Time frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
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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.
Shin Fukudo, MD, PhD principal investigator
Tohoku University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium breve in people with Irritable Bowel Syndrome, run by Tohoku University at 1 site in Japan.
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 20 Aug 2008. 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 Japan. 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.
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 Shin Fukudo, MD, PhD (+81-22-717-8214, sfukudo@mail.tains.tohoku.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate relief and SIBSQ (time frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment). 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 20 Aug 2008.