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NCT03477669 · ClinicalTrials.gov registry record · NA
Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
A NA study, sponsored by University of Nebraska.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03477669: Clinical Trial NA study, sponsored by University of Nebraska.
NCT03477669 is a NA study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03477669, a NA study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty subjects will be randomly assigned to each group for a total enrollment of 60 infants.
Primary Outcome
The investigators will be comparing time on the Baby's Day Diary © from the 1 week run-in to the end of the 4 week period and hope to see a 50% drop in crying time listed on the Baby's Day Diary© .
Interventions
- DIETARY_SUPPLEMENT chamomile/probiotic arm
- DIETARY_SUPPLEMENT Placebo of chamomile/probiotic arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2019-02-25 |
| Phase | NA |
Why NCT03477669 stopped before completion
NCT03477669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which chamomile/probiotic arm is the first listed.
NCT03477669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03477669 about?
NCT03477669 is a clinical study titled "Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants". The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty s...
What is the current status of trial NCT03477669?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-05-18. Estimated completion is 2019-02-25.
What interventions are being tested in trial NCT03477669?
The interventions under investigation include: chamomile/probiotic arm (DIETARY_SUPPLEMENT), Placebo of chamomile/probiotic arm (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03477669?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03477669's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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