The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

NCT ID: NCT01203462

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bifidobacterium supplemented yogurt

Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus

Group Type: EXPERIMENTAL

Probiotic strain of Bifidobacterium

Intervention Type: OTHER

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

Placebo Yogurt

Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus

Group Type: PLACEBO_COMPARATOR

No Bifidobacterium

Intervention Type: OTHER

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

Interventions

Probiotic strain of Bifidobacterium

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

Intervention Type: OTHER

No Bifidobacterium

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cargill

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Merenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Caren Palese, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2010-402

Identifier Type: -

Identifier Source: org_study_id