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NCT01399996 · ClinicalTrials.gov registry record · Phase 1
Influence of a Delivery System on the Efficacy of a Probiotic Intervention
A Phase 1 study of Delayed Transit Time and Irregular Bowel Function, sponsored by Penn State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01399996: Completed Phase 1 study of Delayed Transit Time and Irregular Bowel Function, sponsored by Penn State University.
NCT01399996 is a Phase 1 study of Delayed Transit Time and Irregular Bowel Function that has completed, run by Penn State University. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01399996, a Phase 1 study of Delayed Transit Time and Irregular Bowel Function, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01399996 record still lists
NCT01399996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
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.
NCT01399996 reports a single indexed study location in Pennsylvania.
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.
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).
Who is sponsoring clinical trial NCT01399996?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01399996's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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