Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cargill | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium supplemented yogurt | Experimental | Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
|
| Placebo Yogurt | Placebo Comparator | Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic strain of Bifidobacterium | Other | 4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonic Transit Time | 90 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dan Merenstein, MD | Georgetown University | Principal Investigator |
| Caren Palese, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Department of Family Medicine, Research Division | Washington D.C. | District of Columbia | 20007 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| No Bifidobacterium | Other | 4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added. |
|
| 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 |