A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
1 other identifier
interventional
116
0 countries
N/A
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:
- 1.change of VAS score for abdominal pain/discomfort after 4/8-week treatment
- 2.daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 17, 2015
April 1, 2015
1 year
April 13, 2015
April 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale for abdominal pain
8 weeks
Study Arms (2)
GI Flora
EXPERIMENTALLactobacillus 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)%
placebo
PLACEBO COMPARATORDextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 17, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
April 17, 2015
Record last verified: 2015-04