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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01849991
The ClinicalTrials.gov registry entry for NCT01849991 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01849991 reports 0 study locations.
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.
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