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The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

NCT01203462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2013-02-11

No results posted yet for this study

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.

Conditions

  • Digestive Irregularity
  • Digestive Discomfort
  • History of Straining During Bowel Movements
  • History of Hard or Lumpy Stools

Interventions

OTHER

Probiotic strain of Bifidobacterium

4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.

OTHER

No Bifidobacterium

4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.

Sponsors & Collaborators

  • Cargill

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Dan Merenstein, MD · Georgetown University

  • Caren Palese, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01203462 on ClinicalTrials.gov