Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms (GM-WGTT)
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|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||Phase|
|Non-diarrhea Functional Bowel Symptoms||Other: A probiotic yogurt with inulin Other: Acidified dairy snack||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2009|
|Actual 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 ]
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): 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|