Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|