Clinical trial NCT01203462: The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive Irregularity
Digestive Discomfort
History of Straining During Bowel Movements
History of Hard or Lumpy Stools
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2010-09-16
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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)
* Have access to refrigeration and phone
* Have a history of straining during bowel movements
* Have a history of lumpy or hard stools

Exclusion Criteria:

* 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

Primary outcomes:
measure: Colonic Transit Time
timeFrame: 90 days
Secondary outcomes:
measure: Frequency of bowel movements (daily)
timeFrame: 90 days
measure: Stool consistency (daily)
timeFrame: 90 days
measure: Well being as assessed by agreed upon quality of life instrument
timeFrame: 90 days
measure: Dietary intake survey
timeFrame: 90 days
measure: Tolerance
timeFrame: 90 days
measure: Rome criteria
timeFrame: 90 days
measure: Bristol criteria
timeFrame: 90 days
measure: Recovery of the probiotic in the faeces (quantitative measure)
timeFrame: 90 days
measure: Bacterial composition of the fecal flora
timeFrame: 90 days
measure: Adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Department of Family Medicine, Research Division
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Dan Merenstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Caren Palese, MD
role: PRINCIPAL_INVESTIGATOR
References: