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COMPLETED Phase 1

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

NCT01399996 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DIETARY_SUPPLEMENT Yogurt smoothie without probiotic
  • DIETARY_SUPPLEMENT Yogurt smoothie with probiotic added post fermentation
  • DIETARY_SUPPLEMENT Yogurt smoothie with probiotic added pre-fermentation
  • DIETARY_SUPPLEMENT A capsule containing the probiotic

Study Locations (1)

Pennsylvania

  • Penn State University — University Park

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2012-04
Est. Completion 2014-08
Phase Phase 1

Sponsor

Penn State University

233 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01399996

The ClinicalTrials.gov registry entry for NCT01399996 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 233 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Delayed Transit Time appearing as the primary indexed condition, and to 4 interventions — of which Yogurt smoothie without probiotic is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01399996 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01399996 about?

NCT01399996 is a clinical study titled "Influence of a Delivery System on the Efficacy of a Probiotic Intervention". 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 ...

What is the current status of trial NCT01399996?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-04. Estimated completion is 2014-08.

What conditions does trial NCT01399996 study?

This clinical trial studies the following conditions: Delayed Transit Time, Irregular Bowel Function. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01399996?

The interventions under investigation include: Yogurt smoothie without probiotic (DIETARY_SUPPLEMENT), Yogurt smoothie with probiotic added post fermentation (DIETARY_SUPPLEMENT), Yogurt smoothie with probiotic added pre-fermentation (DIETARY_SUPPLEMENT), A capsule containing the probiotic (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01399996?

This trial is sponsored by Penn State University, which has 233 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01399996 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial