Diarrhea Predominant Irritable Bowel SyndromeNCT01637714
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
A study testing Multi-strain probiotics in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Predominant Irritable Bowel Syndrome
- What is being tested?
- Multi-strain probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Jul 2013
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing to consent/undergo necessary procedures
- between the age of 19 and 75 years
- diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
Who cannot join
- uncontrolled hypertension (Blood pressure > 180/110 mmHg)
- uncontrolled diabetes mellitus (FBS > 200 mg/dL)
- malignancy, cerebrovascular disease, cardiovascular disease
- history of abdominal surgery except appendectomy and hernia repair
- inflammatory bowel disease
- clinically or laboratory-confirmed gastroenteritis
Show all 10Show fewer
- the use of motility drug or dietary fiber supplement in 2 weeks
- serum Cr > 2 x Upper normal limit
- AST or ALT > 2 x Upper normal limit
- Pregnancy, Lactating woman
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Joo Sung Kim, M.D.,PhD, +82-2-740-8112, jooskim@snu.ac.kr
Kyoung Sup Hong, M.D., +82-10-2578-5738, kshong1@empas.com
About this study
Official title: The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.
- Being tested
- Multi-strain probiotics, Placebo powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticsDrug
- B. longum BORI: 1 x 109
- B. bifidum BGN4: 1 x 109
- B. lactis AD011: 1 x 109
- B. infantis IBS007: 1 x 109
- Lactobacillus acidophilus AD031: 1 x 109 three times a day, within 10 minutes after meal, per oral with water
Placebo powderDrug
same taste, shape, dosage as experimental drug
three times a day, within 10 minutes after meal, per oral with water
| Study group | Role | What they receive |
|---|---|---|
| Multi-strain probiotics | Experimental | Not described Receives: Drug: Multi-strain probiotics |
| Placebo powder | Placebo comparator | Not described Receives: Drug: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Irritable bowel syndrome symptom severity score (IBS-SSS)
Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life
Measured: after 8 weeks
Secondary outcomes (5)
Stool frequency and form
Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)
Measured: after 4 weeks and 8 weeks
Symptom control of irritable bowel syndrome
Measured: after 4 weeks and 8 weeks
Improvement of overall symptom in patient with irritable bowel syndrome
Measured: after 4 weeks and 8 weeks
Assessment for quality of life related with irritable bowel syndrome
Measured: after 4 weeks and 8 weeks
Assessment for patient satisfaction after administration completion
Measured: after 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joo Sung Kim, M.D.,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637714
- Sponsor's protocol ID
- Probiotics for IBS
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2012
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01637714
- Acronym / sponsor ID
- Probiotics for IBS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 11 Jul 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.
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant 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 |
|---|---|---|
| Multi-strain probiotics | Experimental | Drug: Multi-strain probiotics |
| Placebo powder | Placebo comparator | Drug: Placebo powder |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willing to consent/undergo necessary procedures
- between the age of 19 and 75 years
- diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
Key exclusion criteria (10 listed)
- uncontrolled hypertension (Blood pressure > 180/110 mmHg)
- uncontrolled diabetes mellitus (FBS > 200 mg/dL)
- malignancy, cerebrovascular disease, cardiovascular disease
- history of abdominal surgery except appendectomy and hernia repair
- inflammatory bowel disease
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 |
|---|---|---|
| Multi-strain probiotics* B. longum BORI: 1 x 109 * B. bifidum BGN4: 1 x 109 * B. lactis AD011: 1 x 109 * B. infantis IBS007: 1 x 109 * Lactobacillus acidophilus AD031: 1 x 109 three times a day, within 10 minutes after meal, per oral with water | Drug | Multi-strain probiotics |
| Placebo powdersame taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water | Drug | Placebo powder |
Primary outcome
change of Irritable bowel syndrome symptom severity score (IBS-SSS)
Time frame: after 8 weeks
Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life
5 secondary outcomes
Stool frequency and form
Time frame: after 4 weeks and 8 weeks
Symptom control of irritable bowel syndrome
Time frame: after 4 weeks and 8 weeks
Improvement of overall symptom in patient with irritable bowel syndrome
Time frame: after 4 weeks and 8 weeks
Assessment for quality of life related with irritable bowel syndrome
Time frame: after 4 weeks and 8 weeks
Assessment for patient satisfaction after administration completion
Time frame: after 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
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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.
Joo Sung Kim, M.D.,PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain probiotics in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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 10 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 18 Jun 2013. 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 South Korea. 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 Joo Sung Kim, M.D., PhD (+82-2-740-8112, jooskim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Irritable bowel syndrome symptom severity score (IBS-SSS) (time frame: after 8 weeks). 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 18 Jun 2013.