Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
|ClinicalTrials.gov Identifier: NCT00618904|
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : July 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pain||Dietary Supplement: Probiotics - Lactobacillus and bifidobacterium Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Efficacy of Probiotic Bacteria in Subjects With Irritable Bowel Syndrome (IBS), Functional Diarrhea, or Functional Bloating|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||September 2007|
Probiotic containing Lactobacillus and Bifidobacterium
Dietary Supplement: Probiotics - Lactobacillus and bifidobacterium
Probiotics administered bid for 6 weeks.
Placebo Comparator: 2
Dietary Supplement: Placebo
Placebo administered bid for 6 weeks.
- The primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.
- Assess the improvement of specific functional bowel disorders (FBD) related symptoms and Health Related Quality of Life (HRQOL).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618904
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7080|
|Principal Investigator:||Yehuda Ringel, MD||University of North Carolina, Chapel Hill|