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NCT01849991 · ClinicalTrials.gov registry record · Phase 1
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01849991: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01849991 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849991, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
Primary Outcome
1. Physical Examination of infants will be performed to evaluate any adverse effects of LR. 2. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Lactobacillus reuteri
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01849991 record still lists
NCT01849991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01849991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849991 about?
NCT01849991 is a clinical study titled "Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic". This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
What is the current status of trial NCT01849991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-09. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01849991?
The interventions under investigation include: Placebo (BIOLOGICAL), Lactobacillus reuteri (BIOLOGICAL).
Who is sponsoring clinical trial NCT01849991?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849991's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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