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

Irritable Bowel Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545037
• Other study ID #: 111005-SCN-BIO-IBS-RA
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2012
• Last updated: July 27, 2017
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Bio-K Plus International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. 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

3. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)

4. Able to understand the nature and purpose of the study including potential risks and side effects

5. 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:

1. Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer

2. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes

3. Any systemic disease that may confound IBS symptoms or compromise subject safety

4. Life expectancy < 6 months

5. Pregnant female or breastfeeding

6. Lactose intolerance

7. Immunodeficient subjects

8. Uncontrolled psychiatric disorder

9. Current treatment with nasogastric tube, ostomy, or parenteral nutrition

10. Eating disorder

11. Recent (< 2 weeks) antibiotic administration

12. History of alcohol, drug, or medication abuse

13. Daily consumption of probiotics, fermented milk, and/or yogurt

14. Known allergies to any substance in the study product

15. Participation in another study with any investigational product within 3 months of screening

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®
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:
• Placebo
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Bio-K Plus International Inc.	Sprim Advanced Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS Adequate Relief (IBS-AR)	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.	12 weeks
Secondary	IBS Global Assessment of Improvement Scale	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".	12 weeks
Secondary	IBS Symptom Severity Scale	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	12 Weeks
Secondary	IBS Quality of Life	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.	12 Weeks
Secondary	Abdominal Pain	Abdominal pain severity will be measured on a 0-10 Likert scale.	12 Weeks
Secondary	Stool Consistency	Stool consistency will be rated with the Bristol Stool Chart.	12 Weeks
Secondary	Stool frequency	Throughout the study, subjects will record the number of defecations per day in a diary.	12 Weeks
Secondary	Concomitant medication use	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.	12 Weeks
Secondary	Adverse Events	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.	12 Weeks