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NCT01657643 · ClinicalTrials.gov registry record · NA

Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections

A NA study, sponsored by University of Medicine and Dentistry of New Jersey.

Completed
Registry status
NA
Development phase
231
Enrollment target

NCT01657643: Completed NA study, sponsored by University of Medicine and Dentistry of New Jersey.

NCT01657643 is a NA study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 231 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01657643, a NA study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.

COMPLETED
Registry status
NA
Development phase
231 participants
Enrollment target

Study Summary

The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt) can improve the health-related quality of life (HRQL) during upper respiratory infections (like the common cold) in college students living in residence hall on-campus at Framingham State University (Framingham, MA) who are randomized to receive a probiotic or placebo candy daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of quality of life (i.e., one's satisfaction with their life) that related specifically to a person's health (for example, ability to carry out normal daily activities). The investigators hypothesize that HRQL during URIs will be significantly higher in the probiotic groups compared to the placebo group. The proposed study will also seek to address the following secondary objectives: missed school and work days due to a upper respiratory infection.

Primary Outcome

Subjects are asked to complete a questionnaire every day for 12 weeks that inquires about any common cold symptoms that they may be experiencing, severity of the symptoms, and how the symptoms interfere with their daily activities. Health-related quality of life is operationalized by total score on the questionnaire.

Interventions

  • DIETARY_SUPPLEMENT placebo
  • DIETARY_SUPPLEMENT Probiotics

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2011-01
Est. Completion 2011-05
Phase NA

What the finished NCT01657643 record still lists

NCT01657643 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01657643 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01657643 about?

NCT01657643 is a clinical study titled "Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections". The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt) can improve the health-related quality of life (HRQL) during upper respiratory infections (like the common cold) in college students living in residence hall on-campus at Framingham State University (Framin...

What is the current status of trial NCT01657643?

This trial is currently completed. It is a NA study. The enrollment target is 231 participants. The study started on 2011-01. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01657643?

The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), Probiotics (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01657643?

This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01657643's enrollment target sits among peer trials

231 465th of 2000 higher than 1,536 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT01657643, the US trial registry maintained by the National Library of Medicine. NCT01657643 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.