NCT01203462

The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

A Probiotic Double-blind Randomized Placebo Crossover Trial of Colonic Transit Time in Adult Females, The PRIDE Study The Study to Determine the Effects of Probiotics on Regulation and Improving Digestive hEalth

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.

Conditions

• Digestive Irregularity
• Digestive Discomfort
• History of Straining During Bowel Movements
• History of Hard or Lumpy Stools

Interventions

Type	Name	Description
OTHER	Probiotic strain of Bifidobacterium	4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.
OTHER	No Bifidobacterium	4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-09-16
• Last updated: 2013-02-11

Locations

1 site across 1 country: United States