The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

Phase 3

Completed

• Conditions: Digestive Irregularity; Digestive Discomfort; History of Straining During Bowel Movements; History of Hard or Lumpy Stools
• Interventions: Other: Probiotic strain of Bifidobacterium; Other: No Bifidobacterium

• Registration Number: NCT01203462
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-12
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bifidobacterium supplemented yogurt	Probiotic strain of Bifidobacterium	Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus
Placebo Yogurt	No Bifidobacterium	Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus

Primary Outcome Measures

Name	Time	Method
Colonic Transit Time	90 days

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Georgetown University Department of Family Medicine, Research Division; 🇺🇸 Washington, District of Columbia, United States