The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bifidobacterium supplemented yogurt Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
Other: Probiotic strain of Bifidobacterium
4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.
|
| Placebo Comparator: Placebo Yogurt Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
Other: No Bifidobacterium
4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.
|
Outcome Measures
Primary Outcome Measures
- Colonic Transit Time [90 days]
Secondary Outcome Measures
- Frequency of bowel movements (daily) [90 days]
- Stool consistency (daily) [90 days]
- Well being as assessed by agreed upon quality of life instrument [90 days]
- Dietary intake survey [90 days]
- Tolerance [90 days]
by questionnaire: e.g. bloating
- Rome criteria [90 days]
- Bristol criteria [90 days]
- Recovery of the probiotic in the faeces (quantitative measure) [90 days]
- Bacterial composition of the fecal flora [90 days]
- Adverse events [90 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
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Have access to refrigeration and phone
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Have a history of straining during bowel movements
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Have a history of lumpy or hard stools
Exclusion Criteria:
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Presence of an allergy or intolerance to any ingredients in yogurt
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Morbid obesity, defined as a BMI>40
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Having inflammatory bowel disease
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Having a history of malabsorption syndrome
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Immunodeficiency, such as HIV or currently receiving chemotherapy
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Consumption of any medications used to treat, prevent or cure diarrhea in the last month
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Consumption of any medications used to treat, prevent or cure constipation in the last month
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Diabetes mellitus
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Thyroid disorders, including hypo- or hyperthyroidism
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History of gastric, small bowel or colonic resection
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Documented history of gastric emptying disorder
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Consumption of narcotics, antipsychotic medications, or verapamil in the last month
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Known pelvic outlet obstruction
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Antibiotic usage within 4 weeks of enrollment
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Georgetown University Department of Family Medicine, Research Division | Washington | District of Columbia | United States | 20007 |
Sponsors and Collaborators
- Georgetown University
- Cargill
Investigators
- Principal Investigator: Dan Merenstein, MD, Georgetown University
- Principal Investigator: Caren Palese, MD, Georgetown University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-402