A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02419027
• Other study ID #: CBT-GS14
• Status: Not yet recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: April 16, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• GI Flora

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for abdominal pain		8 weeks	No