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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

NCT ID: NCT01757054

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-10-31

Brief Summary

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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

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To demonstrate recovery of live probiotic bacteria in the stool.

Conditions

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Fecal Analysis

Keywords

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probiotic LGG BB-12 fecal recovery healthy subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Probiotic group

Group Type EXPERIMENTAL

ProNutrients Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ProNutrients Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4141001&StudyName=Fecal%20recovery%20of%20the%20probiotic%20bacteria%20Lactobacillus%20rhamnosus%20GG%20%28LGG%29%20and%20Bifidobacterium%20Animalis%20subspecies%20Lactis%20BB-12%20%28BB-12%29

To obtain contact information for a study center near you, click here.

Other Identifiers

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PO-10-08

Identifier Type: -

Identifier Source: secondary_id

B4141001

Identifier Type: -

Identifier Source: org_study_id