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Completed

NCT Number: NCT01545037

Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome

The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Digestive and Liver Disease Specialists A Medical Group. Inc, Garden Grove, California, United States

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About this study

Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®

Dietary Supplement

Each capsule contains 50 billion cfu live of Lactobacillus acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® bacterias. The randomized subjects will consume 2 capsules per day at breakfast.

Other names: Bio-K+

Placebo

Other

The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.

Primary outcomes

  1. IBS Adequate Relief (IBS-AR)

    Time frame: 12 weeks

    The IBS-AR is a single-question dichotomous (yes/no) tool that asks subjects if they have experienced adequate relief of IBS symptoms over the past week.

Secondary outcomes

  1. IBS Global Assessment of Improvement Scale

    Time frame: 12 weeks

    The IBS-GAI tool asks a single question regarding how recent IBS symptoms have changed since the start of the study. Subjects answer the question on a 1-7 Likert scale with 1 corresponding to "Substantially Worse" and 7 corresponding to "Substantially Improved".

  2. IBS Symptom Severity Scale

    Time frame: 12 Weeks

    The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale

  3. IBS Quality of Life

    Time frame: 12 Weeks

    The IBS-QOL is a 34-item questionnaire that assesses the degree to which IBS interfered with quality of life for a subject over the past 30 days. Each item is rated on a 1 to 5 Likert scale, with higher values indicating a lower quality of life.

  4. Abdominal Pain

    Time frame: 12 Weeks

    Abdominal pain severity will be measured on a 0-10 Likert scale.

  5. Stool Consistency

    Time frame: 12 Weeks

    Stool consistency will be rated with the Bristol Stool Chart.

  6. Stool frequency

    Time frame: 12 Weeks

    Throughout the study, subjects will record the number of defecations per day in a diary.

  7. Concomitant medication use

    Time frame: 12 Weeks

    Throughout the study, subjects will record use of any concomitant medication and, if required, the need for rescue medication use each day in a diary.

  8. Adverse Events

    Time frame: 12 Weeks

    Adverse events will be assessed throughout this clinical study. The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study.

Sponsors and collaborators

Lead sponsor

Bio-K Plus International Inc.

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study title

Effect of Lactobacillus Acidophilus CL1285®, L. Casei LBC80R® and L. Rhamnosus CLR2® on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2012
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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