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 (LGG BB-12)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Fecal Analysis

Treatments: Dietary Supplement: ProNutrients Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01757054

B4141001

PO-10-08

Details and patient eligibility

About

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.

Full description

To demonstrate recovery of live probiotic bacteria in the stool.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

27 participants in 2 patient groups

Probiotic group

Experimental group

Treatment:

Dietary Supplement: ProNutrients Probiotic

Control group

No Intervention group

Description:

This is a non-supplemented control group that will follow the same dietary and medication restrictions. The purpose of this group is to ensure results are due to supplementation and not due to random dietary exposure.