CompletedPhase 1/2

Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome

Canada100 participantsStarted 2013-06

Plain-language 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. 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 severe IBS.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female subjects aged 18-64. * A diagnosis of Irritable Bowel Syndrome as per ROME III criteria. * A classification of severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score \>300). * 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. Exclusion Criteria: * 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 four 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. * Subjects regularly (\>3 times weekly) consuming probiotics enriched products (e.g. probiotic enriched yogurts, Activia, etc…). * Subjects who have recently (\< 3 months) initiated dietary measures to control IBS s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Irritable Bowel Syndrome Severity

Timeframe: 12 weeks

Trial details

NCT IDNCT01887834

SponsorThe Canadian College of Naturopathic Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials