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Completed

NCT Number: NCT01203462

The PRIDE Study 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic strain of Bifidobacterium

Other

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

No Bifidobacterium

Other

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

Primary outcomes

  1. Colonic Transit Time

    Time frame: 90 days

Secondary outcomes

  1. Frequency of bowel movements (daily)

    Time frame: 90 days

  2. Stool consistency (daily)

    Time frame: 90 days

  3. Well being as assessed by agreed upon quality of life instrument

    Time frame: 90 days

  4. Dietary intake survey

    Time frame: 90 days

  5. Tolerance

    Time frame: 90 days

    by questionnaire: e.g. bloating

  6. Rome criteria

    Time frame: 90 days

  7. Bristol criteria

    Time frame: 90 days

  8. Recovery of the probiotic in the faeces (quantitative measure)

    Time frame: 90 days

  9. Bacterial composition of the fecal flora

    Time frame: 90 days

  10. Adverse events

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Cargill

Registry information

Official study 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

Acronym: PRIDE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2010
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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