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Influence of a Delivery System on the Efficacy of a Probiotic Intervention

NCT01399996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-21

No results posted yet for this study

Summary

In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.

Conditions

  • Delayed Transit Time
  • Irregular Bowel Function

Interventions

DIETARY_SUPPLEMENT

Yogurt smoothie without probiotic

A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).

DIETARY_SUPPLEMENT

Yogurt smoothie with probiotic added post fermentation

A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).

DIETARY_SUPPLEMENT

Yogurt smoothie with probiotic added pre-fermentation

A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).

DIETARY_SUPPLEMENT

A capsule containing the probiotic

A capsule taken daily will provide between 10x\^y9 and 10x\^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).

Sponsors & Collaborators

  • Dairy Management Inc.

    collaborator INDUSTRY

  • Penn State University

    lead OTHER

Principal Investigators

  • Penny M Kris-Etherton, PhD · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399996 on ClinicalTrials.gov