Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Irritable Bowel Syndrome
In brief
The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.
Key facts
- Study ID
- NCT01545037
- Run by
- Bio-K Plus International Inc.
- People needed
- 117
- Starts
- 2012-07-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18 years or older
- Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:
- Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Symptom onset must be at least 6 months prior to diagnosis
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand the nature and purpose of the study including potential risks and side effects
- Willing to consent to study participation and to comply with study requirements
- Abdominal pain or discomfort at least 2 days during run-in period associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Completion of all study-related questionnaires
You may not qualify if…
- Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
- Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
- Any systemic disease that may confound IBS symptoms or compromise subject safety
- Life expectancy < 6 months
- Pregnant female or breastfeeding
- Lactose intolerance
- Immunodeficient subjects
- Uncontrolled psychiatric disorder
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Eating disorder
- Recent (< 2 weeks) antibiotic administration
- History of alcohol, drug, or medication abuse
- Daily consumption of probiotics, fermented milk, and/or yogurt
- Known allergies to any substance in the study product
- Participation in another study with any investigational product within 3 months of screening
Where it is running
- Digestive and Liver Disease Specialists A Medical Group. Inc — Garden Grove, California, United States
- Sprim ALS — San Francisco, California, United States
- Westlake Medical Research — Westlake Village, California, United States
Full record on ClinicalTrials.gov
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