The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth - Full Text View

Purpose

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	Intervention	Phase
Digestive Irregularity Digestive Discomfort History of Straining During Bowel Movements History of Hard or Lumpy Stools	Other: Probiotic strain of Bifidobacterium Other: No Bifidobacterium	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

Colonic Transit Time [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of bowel movements (daily) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Stool consistency (daily) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Well being as assessed by agreed upon quality of life instrument [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Dietary intake survey [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Tolerance [ Time Frame: 90 days ] [ Designated as safety issue: No ]
by questionnaire: e.g. bloating
Rome criteria [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Bristol criteria [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Recovery of the probiotic in the faeces (quantitative measure) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Bacterial composition of the fecal flora [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment:	68
Study Start Date:	October 2010
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203462

Locations

United States, District of Columbia
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

More Information

No publications provided

Responsible Party:	Georgetown University
ClinicalTrials.gov Identifier:	NCT01203462 History of Changes
Other Study ID Numbers:	2010-402
Study First Received:	September 15, 2010
Last Updated:	February 8, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013