Fecal Analysis
Conditions
Keywords
probiotic, LGG, BB-12, fecal recovery, healthy subjects
Brief summary
The main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria.
Detailed description
To demonstrate recovery of live probiotic bacteria in the stool.
Interventions
DIETARY_SUPPLEMENTProNutrients Probiotic
Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Are between 18-70 years of age. Have regular bowel movements. Are willing and able to attend study visits, undergo limited blood and urine testing, take the nutritional supplement according to the instructions provided. Are willing to collect four stool specimens and bring them to the study site.
Exclusion criteria
Are unwilling to follow the dietary guidelines of the study. Are lactose-intolerant or have allergies to milk or wheat. Have had drug or alcohol problems within the previous year. Are or plan to become pregnant over the next 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks | Baseline, 3 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 2 weeks | Baseline, 2 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR |
| Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 3 weeks | Baseline, 3 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) |
| Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 3 weeks | Baseline, 3 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group |
| Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 2 weeks | Baseline, 2 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group |
| Change in fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR at baseline, 3 weeks, and 28 days post supplementation | Baseline, 3 weeks, 28 days follow up | Post-supplementation fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR compared to baseline and 3 week supplementation values |
| Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 2 weeks | Baseline, 2 weeks | Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) |
Countries
United States
Outcome results
None listed