Fecal Recovery of the Probiotic Bacteria Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis BB-12 (BB-12) in Healthy Humans Following Daily Consumption of a Probiotic Supplement

Pfizer27 enrolled

Overview

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.

To demonstrate recovery of live probiotic bacteria in the stool.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Fecal Analysis

Interventions

ProNutrients ProbioticDIETARY_SUPPLEMENT

Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks

Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR

Time frame: Baseline, 3 weeks

Secondary Outcomes

Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 2 weeks

Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR

Time frame: Baseline, 2 weeks

Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 3 weeks

Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR)

Time frame: Baseline, 3 weeks

Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 2 weeks

Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR)

Time frame: Baseline, 2 weeks

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

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

Time frame: Baseline, 3 weeks

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

Data from ClinicalTrials.gov

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