The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth (PRIDE)

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

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.

Study Overview

• Status: Completed
• Conditions: Digestive Irregularity; Digestive Discomfort; History of Straining During Bowel Movements; History of Hard or Lumpy Stools
• Intervention / Treatment: Other: Probiotic strain of Bifidobacterium; Other: No Bifidobacterium

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Department of Family Medicine, Research Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colonic Transit Time	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		90 days
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	by questionnaire: e.g. bloating	90 days
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

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Cargill
• Investigators: Principal Investigator: Dan Merenstein, MD, Georgetown University; Principal Investigator: Caren Palese, MD, Georgetown University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2010-402