Status:
COMPLETED
The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Cargill
Conditions:
Digestive Irregularity
Digestive Discomfort
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief 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 adminis...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01203462
Start Date
October 1 2010
End Date
July 1 2011
Last Update
February 11 2013
Active Locations (1)
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1
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, United States, 20007