Trials / Completed
CompletedNCT02839239
Lactocare Baby Drops in Infants Colic
Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Biocare Copenhagen A/S · Industry
- Sex
- All
- Age
- 4 Weeks – 12 Weeks
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC. The active group of infants will receive lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups
Detailed description
There is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant colic, the condition that affects around 1 of 4-5 infants. The interest for dietary supplementation has been evoked by a line of earlier studies, indicating that infants with colic had an increased number of gas-forming E.coli in the intestines and potential interference between lactobacilli and E.coli. Systematic review of evidence, based on the 6 randomized controlled dietary studies, conducted in Italy, Poland, Australia, Canada, and Finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day after the 3 weeks dietary course with lactobacilli . In the mentioned studies most commonly used lactobacilli were L. reuteri, however, the effect of combination of L. reuteri with other lactobacilli remains unknown.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Drops with lactobacilli and vitamin D3 | Oil suspension with lactobacilli and vitamin D3 |
| DIETARY_SUPPLEMENT | Drops with vitamin D3 | Oil suspension with vitamin D3 |
Timeline
- Start date
- 2016-12-09
- Primary completion
- 2018-01-15
- Completion
- 2018-01-15
- First posted
- 2016-07-20
- Last updated
- 2018-01-18
Source: ClinicalTrials.gov record NCT02839239. Inclusion in this directory is not an endorsement.