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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

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Boston, Massachusetts, 02111 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fecal Analysis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT01757054
Pfizer
Completed
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

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionTo demonstrate recovery of live probiotic bacteria in the stool.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Fecal Analysis
Intervention  ICMJE Dietary Supplement: ProNutrients Probiotic
Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days
Study Arms  ICMJE
  • Experimental: Probiotic group
    Intervention: Dietary Supplement: ProNutrients Probiotic
  • No Intervention: 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.
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2013)
27
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2012)
28
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion DateOctober 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757054
Other Study ID Numbers  ICMJE B4141001
PO-10-08
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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