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

Phase 4

Completed

• Conditions: Fecal Analysis
• Interventions: Dietary Supplement: ProNutrients Probiotic

• Registration Number: NCT01757054
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Study Start: 2013-02
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	ProNutrients Probiotic	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Boston, Massachusetts, United States