The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Probiotic strain of Bifidobacterium
* Other: No Bifidobacterium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium supplemented yogurt<br>Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus | Other: Probiotic strain of Bifidobacterium<br>* 4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.<br>|
| Placebo Comparator: Placebo Yogurt<br>Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus | Other: No Bifidobacterium<br>* 4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic Transit Time |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | by questionnaire: e.g. bloating | 90 days | 
| 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 | 
| Adverse events |  | 90 days |