Back to resultsA Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GI Flora
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring GI Flora
Eligibility Criteria
Inclusion Criteria:
- Irritable bowel syndrome patients according to Rome III criteria
- Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
Exclusion Criteria:
- Intolerable or hypersensitive to GI Flora.
- Patients with active colon diverticulitis.
- History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation.
- History of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years.
- Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GI Flora
placebo
Arm Description
Lactobacillus acidophilus LA1 1.312% Lactobacillus rhamnosus LR5 0.656% Lactobacillus paracasei LPC5 0.656% Bifidobacterium lactis BL3 1.312% Bifidobacterium breve BR3 1.312% Pediococcus pentosaceus SL4 1.312% Prolac-T(heat-killed L. acidophilus LA1) 24.286% Dextrose 60.000% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
Outcomes
Primary Outcome Measures
Visual Analogue Scale for abdominal pain
Secondary Outcome Measures
Full Information
NCT ID
NCT02419027
First Posted
April 13, 2015
Last Updated
April 16, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02419027
Brief Title
A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel Syndrome.
Regimen: 6 probiotics mixture >10^9/D for 8 weeks
Primary variable: visual analogue scale(VAS) assessment for abdominal pain
Secondary variable:
change of VAS score for abdominal pain/discomfort after 4/8-week treatment
daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
GI Flora
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GI Flora
Arm Type
Experimental
Arm Description
Lactobacillus acidophilus LA1 1.312% Lactobacillus rhamnosus LR5 0.656% Lactobacillus paracasei LPC5 0.656% Bifidobacterium lactis BL3 1.312% Bifidobacterium breve BR3 1.312% Pediococcus pentosaceus SL4 1.312% Prolac-T(heat-killed L. acidophilus LA1) 24.286% Dextrose 60.000% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Flora
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Visual Analogue Scale for abdominal pain
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Irritable bowel syndrome patients according to Rome III criteria
Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
Exclusion Criteria:
Intolerable or hypersensitive to GI Flora.
Patients with active colon diverticulitis.
History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation.
History of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years.
Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.
12. IPD Sharing Statement
Learn more about this trial
A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
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