Diarrhea Predominant Irritable Bowel SyndromeNCT01373034
The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
A study testing Soy Dietary Fiber and Rice powder 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 soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diarrhea Predominant Irritable Bowel Syndrome
- What is being tested?
- Soy Dietary Fiber and Rice powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2012
- 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
- No healthy volunteers
- 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 > 170/100 mmHg)
- uncontrolled diabetes mellitus (FBS > 180 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 11Show fewer
- the use of motility drug or dietary fiber supplement in 2 weeks
- allergy to soy fiber
- 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
Seoul National University Hospital
Seoul, 110-744
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 Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial
The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
- Being tested
- Soy Dietary Fiber, Rice powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy Dietary FiberDietary supplement
Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
Rice powderDietary supplement
Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL
| Study group | Role | What they receive |
|---|---|---|
| Soy Dietary Fiber | Experimental | Not described Receives: Dietary Supplement: Soy Dietary Fiber |
| Rice powder | Placebo comparator | Not described Receives: Dietary Supplement: Rice powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
sum of irritable bowel syndrome symptom score
abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
Measured: after 4 weeks
Secondary outcomes (8)
irritable bowel syndrome symptom score
abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
Measured: after 2 weeks and 4 weeks
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 2 weeks and 4 weeks
Symptom control of irritable bowel syndrome
Measured: after 2 weeks and 4 weeks
Improvement of overall symptom in patient with irritable bowel syndrome
Measured: after 2 weeks and 4 weeks
Severity of overall symptom in patient with irritable bowel syndrome
Measured: after 2 weeks and 4 weeks
Severity of diarrhea
Measured: after 2 weeks and 4 weeks
Assessment for quality of life related with irritable bowel syndrome
Measured: after 2 weeks and 4 weeks
Assessment for patient satisfaction after administration completion
Overall satisfaction for treatment Whether the patient will keep up treatment
Measured: after 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Joo Sung Kim, M.D., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373034
- Sponsor's protocol ID
- CHUNG_SOY
- Status last verified
- Jun 2011
- First submitted
- 13 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial
- ClinicalTrials.gov ID
- NCT01373034
- Acronym / sponsor ID
- CHUNG_SOY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 Jun 2011 (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 soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Dietary Fiber | Experimental | Dietary Supplement: Soy Dietary Fiber |
| Rice powder | Placebo comparator | Dietary Supplement: Rice powder |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not 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 (11 listed)
- uncontrolled hypertension (Blood pressure > 170/100 mmHg)
- uncontrolled diabetes mellitus (FBS > 180 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 |
|---|---|---|
| Soy Dietary FiberSoy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL | Dietary supplement | Soy Dietary Fiber |
| Rice powderRice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL | Dietary supplement | Rice powder |
Primary outcome
sum of irritable bowel syndrome symptom score
Time frame: after 4 weeks
abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
8 secondary outcomes
irritable bowel syndrome symptom score
Time frame: after 2 weeks and 4 weeks
Stool frequency and form
Time frame: after 2 weeks and 4 weeks
Symptom control of irritable bowel syndrome
Time frame: after 2 weeks and 4 weeks
Improvement of overall symptom in patient with irritable bowel syndrome
Time frame: after 2 weeks and 4 weeks
Severity of overall symptom in patient with irritable bowel syndrome
Time frame: after 2 weeks and 4 weeks
Severity of diarrhea
Time frame: after 2 weeks and 4 weeks
Assessment for quality of life related with irritable bowel syndrome
Time frame: after 2 weeks and 4 weeks
Assessment for patient satisfaction after administration completion
Time frame: after 2 weeks and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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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 Soy Dietary Fiber and Rice powder 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 11 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 14 Jun 2011. 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?
sum of irritable bowel syndrome symptom score (time frame: after 4 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 14 Jun 2011.