Irritable Bowel SyndromePhase 1/2NCT01176227
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
A Phase 1/2 study testing Kyodophilus multi-strain probiotic capsules in people with Irritable Bowel Syndrome and Digestive System Diseases, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
Trial summary
The Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional
- What is being tested?
- Kyodophilus multi-strain probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects aged 18-64
- A diagnosis of Irritable Bowel Syndrome as per ROME III criteria
- A classification of mild irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score >75)
- Female subjects currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods)
- Subjects who agree to maintain their current eating habits throughout the study
- Ability to understand and sign the Informed Consent Form
Who cannot join
- Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months
- Subjects currently receiving medication for the treatment of IBS symptoms
- Subjects currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the trial is they agree to undergo a two week washout period
- Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
- Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
- Subjects currently receiving antibiotic therapy or antibiotic therapy within the previous month
Show all 17Show fewer
- Subjects regularly consuming probiotic containing products (e.g. yogurts, etc.)
- Subjects who have recently (< 3 months) initiated dietary measures to control IBS symptoms
- Subjects with a history of major or complicated gastrointestinal surgery
- Subjects with severe endometriosis
- Subjects with malignant tumors or subjects undergoing chemotherapy or radiation therapy
- Subjects with severe IBS and that require medication
- Subjects with weight loss, anaemia, inflammatory bowel disease, celiac sprue, family history of colorectal cancer
- Subjects exhibiting or indicating thoughts of suicide currently or in the past as based on patient screening interview by the investigator/clinician. Appropriate referral to a health care provider will be provided
- Subjects with known allergies to milk or milk based products
- Subjects using and/or have used antipsychotic or anticholinergic medication within the prior month, those with reported significant abnormalities on the thyroid function tests, blood counts and serum chemistry
- Subjects 50 years or older who have been diagnosed with IBS and have not received a colonoscopy in the last five years.
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2
About this study
Official title: The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Irritable Bowel Syndrome (IBS)
The Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and bloating.
The medicines that are currently used to help people with IBS are not as effective as we would like them to be. These medicines are usually only prescribed to reduce the pain of IBS and not actually treat the disorder itself. Recently, scientists have found that probiotics (beneficial bacteria that live inside humans) may help reduce the painful symptoms and diarrhea that are part of IBS.
This research is being conducted to determine whether this particular combination of three probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum) will reduce the symptoms of IBS.
Read the detailed description
The purpose of this trial is to investigate the effects of the three strain probiotic, Kyo-Dophilus, on the symptoms associated with Irritable Bowel Syndrome.
The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with Irritable Bowel Syndrome by ROME III criteria and classified as mild through the Irritable Bowel Severity Scoring System and to measuring quality of life and global well being of patients through the Visual Analog Scale and the Irritable Bowel Syndrome-Quality of Life Questioner. The secondary objective is to assess the tolerability of the treatment through the use of study diaries.
- Conditions
- Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional, Colitis, Mucous, Colon, Irritable
- Being tested
- Kyodophilus multi-strain probiotic capsules, Kyodophilus Matching Placebo Capsules
- Keywords
- bloating, constipation, diarrhea, gas, mucous, cramping
- Medical subject headings
- Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional, Constipation, Diarrhea, Mucopolysaccharidosis IV, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyodophilus multi-strain probiotic capsulesDietary supplement
The Kyo-Dophilus study product is a gelatin capsule containing three proprietary probiotic bacterial strains. The total quantity of bacteria per capsule is 1.5 billion colony forming units (1.5 x 109 cfu) and is composed of the following strains:
- Lactobacillus gasseri KS-13 1.2
- Bifidobacterium bifidum G9-1 0.15
- Bifidobacterium longum MM-2 0.15
Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.
Kyodophilus Matching Placebo CapsulesDietary supplement
Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Kyodophilus matching placebo capsules | Placebo comparator | Not described Receives: Dietary Supplement: Kyodophilus Matching Placebo Capsules |
| Kyodophilus multi strain probiotic capsules | Active comparator | Not described Receives: Dietary Supplement: Kyodophilus multi-strain probiotic capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The irrtable bowel severity scoring system is the primary outcome measure
Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).
Measured: 12 weeks (between baseline and end of study)
Secondary outcomes (3)
Tolerability of the treatment will be assessed through the use of study diaries in which adverse events will be recorded.
Measured: 12 weeks
The Irritable Bowel Syndrome-Quality of Life Questionnaire
This is a validated quality of life questionnaire (Patrick et al, 1998)
Measured: 12 weeks (baseline and end of study)
Visual Analogue Scale
Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms
Measured: 12 weeks (baseline and end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd., Dicentra Inc.
- Investigators
- Dugald Seely, ND, Principal investigator, The Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176227
- Sponsor's protocol ID
- 1001
- Status last verified
- Mar 2011
- First submitted
- 31 May 2010
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT01176227
- Acronym / sponsor ID
- 1001
- Conditions
- Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional, Colitis, Mucous, Colon, Irritable
- Keywords
- bloating, constipation, diarrhea, gas, mucous, cramping
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd., Dicentra Inc.
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Aug 2010 (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 Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and bloating.
The medicines that are currently used to help people with IBS are not as effective as we would like them to be. These medicines are usually only prescribed to reduce the pain of IBS and not actually treat the disorder itself. Recently, scientists have found that probiotics (beneficial bacteria that live inside humans) may help reduce the painful symptoms and diarrhea that are part of IBS.
This research is being conducted to determine whether this particular combination of three probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum) will reduce the symptoms of IBS.
Detailed description
The purpose of this trial is to investigate the effects of the three strain probiotic, Kyo-Dophilus, on the symptoms associated with Irritable Bowel Syndrome.
The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with Irritable Bowel Syndrome by ROME III criteria and classified as mild through the Irritable Bowel Severity Scoring System and to measuring quality of life and global well being of patients through the Visual Analog Scale and the Irritable Bowel Syndrome-Quality of Life Questioner. The secondary objective is to assess the tolerability of the treatment through the use of study diaries.
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 |
|---|---|---|
| Kyodophilus matching placebo capsules | Placebo comparator | Dietary Supplement: Kyodophilus Matching Placebo Capsules |
| Kyodophilus multi strain probiotic capsules | Active comparator | Dietary Supplement: Kyodophilus multi-strain probiotic capsules |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects aged 18-64
- A diagnosis of Irritable Bowel Syndrome as per ROME III criteria
- A classification of mild irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score >75)
- Female subjects currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods)
- Subjects who agree to maintain their current eating habits throughout the study
Key exclusion criteria (17 listed)
- Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months
- Subjects currently receiving medication for the treatment of IBS symptoms
- Subjects currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the trial is they agree to undergo a two week washout period
- Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
- Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
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 |
|---|---|---|
| Kyodophilus multi-strain probiotic capsulesThe Kyo-Dophilus study product is a gelatin capsule containing three proprietary probiotic bacterial strains. The total quantity of bacteria per capsule is 1.5 billion colony forming units (1.5 x 109 cfu) and is composed of the following strains: * Lactobacillus gasseri KS-13 1.2 * Bifidobacterium bifidum G9-1 0.15 * Bifidobacterium longum MM-2 0.15 Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2. | Dietary supplement | Kyodophilus multi strain probiotic capsules |
| Kyodophilus Matching Placebo CapsulesSubjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2. | Dietary supplement | Kyodophilus matching placebo capsules |
Primary outcome
The irrtable bowel severity scoring system is the primary outcome measure
Time frame: 12 weeks (between baseline and end of study)
Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).
3 secondary outcomes
Tolerability of the treatment will be assessed through the use of study diaries in which adverse events will be recorded.
Time frame: 12 weeks
The Irritable Bowel Syndrome-Quality of Life Questionnaire
Time frame: 12 weeks (baseline and end of study)
Visual Analogue Scale
Time frame: 12 weeks (baseline and end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Dugald Seely, ND principal investigator
The Canadian College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kyodophilus multi-strain probiotic capsules in people with Irritable Bowel Syndrome and Digestive System Diseases, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 1 Apr 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The irrtable bowel severity scoring system is the primary outcome measure (time frame: 12 weeks (between baseline and end of study)). 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 1 Apr 2011.