Drops with lactobacilli and vitamin D3
Dietary SupplementOil suspension with lactobacilli and vitamin D3
NCT Number: NCT02839239
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
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Notify Me4 week–12 week
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oil suspension with lactobacilli and vitamin D3
Oil suspension with vitamin D3
Time frame: 28 days
Change in mean cry/fuss time
Time frame: 28 days
Change in mean cry time
Time frame: 28 days
Change in mean fuss time
Time frame: 7, 14, 21, 28 days
Outcome Measure Description
Time frame: 7, 14, 21, 28 days
Recovery success
Time frame: 7, 14, 21, 28 days
Cry and fuss time
Time frame: 7, 14, 21, 28 days
Infant sleep duration
Time frame: 28 days
Change in maternal depression score
Biocare Copenhagen A/S
Industry
Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
Acronym: LACONIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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