The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

• Frequency of bowel movements (daily) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Stool consistency (daily) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Well being as assessed by agreed upon quality of life instrument [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Dietary intake survey [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Tolerance [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  by questionnaire: e.g. bloating
• Rome criteria [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Bristol criteria [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Recovery of the probiotic in the faeces (quantitative measure) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Bacterial composition of the fecal flora [ Time Frame: 90 days ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

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.

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

• 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.

• 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
  Intervention: Other: Probiotic strain of Bifidobacterium
• Placebo Comparator: Placebo Yogurt
  Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus
  Intervention: Other: No Bifidobacterium

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