Lactocare Baby Drops in Infants Colic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study

Conditions
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Infant Colic

Intervention / Treatment
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* Dietary Supplement: Drops with lactobacilli and vitamin D3
* Dietary Supplement: Drops with vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed by both parents. Gender: males and females; Age: 4 -12 weeks; Infant colic, defined as cry/fussing lasting > 3 h, occurring > 3 d for 7 days; Gestational age 37-42 weeks; Birth weight 2,500-4,200 g; Stated availability throughout the study period; Sated availability of mobile phone or phone with answering machine. Exclusion Criteria: Any formula feeding in any amount; Failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry); Current maternal smoking; Known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune); Present intake of antibiotics by infant or mother; Present intake of prebiotics or probiotics by infant or mother; Difficulty of parents to comprehend study requirements as judged by the physician; Suspected parental alcohol or drug addiction as judged by the physician.

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drops with lactobacilli and vitamin D3<br>Exclusive breast feeding plus L. rhamnosus 19070-2 and L. reuteri DSM 12246 in a dose of 125 x 106 CFU (both strains) with 1,667 mg fructooligosaccharides and 2,5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days. | Dietary Supplement: Drops with lactobacilli and vitamin D3<br>* Oil suspension with lactobacilli and vitamin D3<br>|
| Placebo Comparator: Drops with vitamin D3<br>Exclusive breast feeding plus 2.5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days. | Dietary Supplement: Drops with vitamin D3<br>* Oil suspension with vitamin D3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean cry/fuss time (min/day) from day 0 through day 28 | Change in mean cry/fuss time | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean cry time (min/day) from day 0 through day 28 | Change in mean cry time | 28 days | 
| Change in mean fuss time (min/day) from day 0 through day 28 | Change in mean fuss time | 28 days | 
| Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline | Outcome Measure Description | 7, 14, 21, 28 days | 
| Recovery success (percent) at 7, 14, 21, 28 days, defined as reduction in duration of cry time less than 3 hours per day (unmet Wessel criteria); | Recovery success | 7, 14, 21, 28 days | 
| Cry and fuss time (min/day) on days 0, 7, 14, 21, 28 | Cry and fuss time | 7, 14, 21, 28 days |