Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome - Full Text View

Purpose

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

Condition	Intervention	Phase
Irritable Bowel Syndrome	Dietary Supplement: Lactobacillus acidophilus and Lactobacillus casei Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Lactobacillus Acidophilus CL1285 and Lactobacillus Casei LBC80R on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study

Resource links provided by NLM:

Drug Information available for: Lactobacillus acidophilus Lactobacillus

U.S. FDA Resources

Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:

IBS Adequate Relief (IBS-AR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 Outcome Measures:

IBS Global Assessment of Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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".
IBS Symptom Severity Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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
IBS Quality of Life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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.
Abdominal Pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Abdominal pain severity will be measured on a 0-10 Likert scale.
Stool Consistency [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Stool consistency will be rated with the Bristol Stool Chart.
Stool frequency [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Throughout the study, subjects will record the number of defecations per day in a diary.
Concomitant medication use [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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.
Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	117
Study Start Date:	July 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Probiotic capsules Lactobacillus acidophilus CL1285® + Lactobacillus casei LBC80R®	Dietary Supplement: Lactobacillus acidophilus and Lactobacillus casei Each capsule contains of Lactobacillus acidophilus CL1285® + Lactobacillus casei LBC80R® contains50 billion cfu live bacteria. The randomized subjects will consume 2 capsules per day at breakfast. Other Name: Bio-K+
Placebo Comparator: Placebo The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.	Other: Placebo The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.

Detailed Description:

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® and Lactobacillus casei LBC80R®, on symptoms of IBS in otherwise healthy adults.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545037

Contacts

Contact: Karen Buchea Cravotto

1.415.291.2020

karen.cravotto@sprim.com

Locations

United States, California
Digestive and Liver Disease Specialists A Medical Group. Inc	Recruiting
Garden Grove, California, United States, 92840
Principal Investigator: Syam P. Gaddam, MD
Sprim ALS	Recruiting
San Francisco, California, United States, 94109
Principal Investigator: Dalia Perleman, MS,RD,CDE
Westlake Medical Research	Recruiting
Westlake Village, California, United States, 91631
Principal Investigator: Razmig Krumian, DO

Sponsors and Collaborators

Bio-K Plus International Inc.

Sprim Advanced Life Sciences

Investigators

Principal Investigator:	Dalia Perelman, MS,RD,CDE	SPRIM ALS
Principal Investigator:	Syam P. Gaddam, MD	Digestive and Liver Disease Specialists A medical Group Inc.
Principal Investigator:	Razming Krumian, DO	Westlake Medical Research

More Information

No publications provided

Responsible Party:	Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:	NCT01545037 History of Changes
Other Study ID Numbers:	111005-SCN-BIO-IBS-RA
Study First Received:	March 1, 2012
Last Updated:	August 28, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013