Completed

NCT Number: NCT01757054

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

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.

Completed

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Key information

Conditions

Fecal Analysis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Boston, Massachusetts, 02111, United States

About this study

To demonstrate recovery of live probiotic bacteria in the stool.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProNutrients Probiotic

Dietary Supplement

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

Primary outcomes

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

Time frame: Baseline, 3 weeks

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

Secondary outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Randomized, Two Arm, Parallel Group, Open Label, Single Center Prospective Study of the Fecal Recovery of Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis (BB-12) in Healthy Humans Following Daily Consumption of ProNutrients Probiotic Powder Sachet

Acronym: LGG BB-12

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Dec 28, 2012
Registry last updated: Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.