Lactocare Baby Drops in Infants Colic

Not Applicable

Completed

• Conditions: Infant Colic
• Interventions: Dietary Supplement: Drops with vitamin D3; Dietary Supplement: Drops with lactobacilli and vitamin D3

• Registration Number: NCT02839239
• Lead Sponsor: Biocare Copenhagen A/S

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-20
• Study Start: 2016-12-09
• Status Verified: 2018-01
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Informed consent form signed by both parents.
2. Gender: males and females;
3. Age: 4 -12 weeks;
4. Infant colic, defined as cry/fussing lasting > 3 h, occurring > 3 d for 7 days;
5. Gestational age 37-42 weeks;
6. Birth weight 2,500-4,200 g;
7. Stated availability throughout the study period;
8. Sated availability of mobile phone or phone with answering machine.

Exclusion Criteria

1. Any formula feeding in any amount;
2. Failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry);
3. Current maternal smoking;
4. Known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune);
5. Present intake of antibiotics by infant or mother;
6. Present intake of prebiotics or probiotics by infant or mother;
7. Difficulty of parents to comprehend study requirements as judged by the physician;
8. Suspected parental alcohol or drug addiction as judged by the physician.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drops with vitamin D3	Drops with vitamin D3	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.
Drops with lactobacilli and vitamin D3	Drops with lactobacilli and vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
Change in mean cry/fuss time (min/day) from day 0 through day 28	28 days	Change in mean cry/fuss time

Secondary Outcome Measures

Name	Time	Method
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);	7, 14, 21, 28 days	Recovery success
Cry and fuss time (min/day) on days 0, 7, 14, 21, 28	7, 14, 21, 28 days	Cry and fuss time
Change in mean cry time (min/day) from day 0 through day 28	28 days	Change in mean cry time
Change in mean fuss time (min/day) from day 0 through day 28	28 days	Change in mean fuss time
Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline	7, 14, 21, 28 days	Outcome Measure Description