Digestive Discomfort, Digestive Irregularity, History of Hard or Lumpy Stools, History of Straining During Bowel Movements
Conditions
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.
Interventions
OTHERProbiotic strain of Bifidobacterium
4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.
OTHERNo Bifidobacterium
4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.
Sponsors
Cargill
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonic Transit Time | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency (daily) | 90 days | — |
| Well being as assessed by agreed upon quality of life instrument | 90 days | — |
| Dietary intake survey | 90 days | — |
| Tolerance | 90 days | by questionnaire: e.g. bloating |
| Frequency of bowel movements (daily) | 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 | — |
| Rome criteria | 90 days | — |
Countries
United States
Outcome results
None listed