The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
Completed · Phase 3 · Has a placebo group
Conditions studied: Digestive Irregularity, Digestive Discomfort, History of Straining During Bowel Movements, History of Hard or Lumpy Stools
In brief
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.
Key facts
- Study ID
- NCT01203462
- Run by
- Georgetown University
- People needed
- 68
- Starts
- 2010-10-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2013-02-11
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Being female
- Ability to speak and write English or Spanish
- Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
- Have access to refrigeration and phone
- Have a history of straining during bowel movements
- Have a history of lumpy or hard stools
You may not qualify if…
- Presence of an allergy or intolerance to any ingredients in yogurt
- Morbid obesity, defined as a BMI>40
- Having inflammatory bowel disease
- Having a history of malabsorption syndrome
- Immunodeficiency, such as HIV or currently receiving chemotherapy
- Consumption of any medications used to treat, prevent or cure diarrhea in the last month
- Consumption of any medications used to treat, prevent or cure constipation in the last month
- Diabetes mellitus
- Thyroid disorders, including hypo- or hyperthyroidism
- History of gastric, small bowel or colonic resection
- Documented history of gastric emptying disorder
- Consumption of narcotics, antipsychotic medications, or verapamil in the last month
- Known pelvic outlet obstruction
- Antibiotic usage within 4 weeks of enrollment
- Pregnancy
Where it is running
- Georgetown University Department of Family Medicine, Research Division — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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