Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms (GM-WGTT)
|ClinicalTrials.gov Identifier: NCT01004484|
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : December 21, 2010
- Daily consumption of yogurt containing probiotic bacteria (Bb12) and inulin will significantly decrease whole gut and intestinal segmental transit time
- The effect of accelerating intestinal transit will be associated with other GI physiology parameters including stool frequency and stool consistency.
|Condition or disease||Intervention/treatment|
|Non-diarrhea Functional Bowel Symptoms||Other: A probiotic yogurt with inulin Other: Acidified dairy snack|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Physiological Effects of Yogurt Containing Bifidobacterium Lactis (Bb12) in Subjects With Non-Diarrhea Functional Gastrointestinal Symptoms|
|Study Start Date :||June 2009|
|Primary Completion Date :||December 2009|
|Study Completion Date :||April 2010|
Active Comparator: Yogurt with probiotics and inulin
A probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving).
Other: A probiotic yogurt with inulin
A 4 oz. cup with a probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving), once daily.
Placebo Comparator: Placebo
Acidified dairy snack without yogurt cultures, probiotic or inulin.
Other: Acidified dairy snack
A 4 oz. cup of acidified dairy snack, once daily.
- The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPill™ [ Time Frame: 10-28 days ]
- Secondary outcome measures (a) Stool frequency (b) Stool consistency (c) Gastric emptying and small bowel transit time [ Time Frame: 10-28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004484
|United States, North Carolina|
|UNC-CH Program of Digestive Health|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Tamar Ringel-Kulka, MD, MPH||University of North Carolina, Chapel Hill|