Lactocare Baby Drops in Infants Colic (LACONIC)

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

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

Study Overview

• Status: Completed
• Conditions: Infant Colic
• Intervention / Treatment: Dietary supplement: Drops with lactobacilli and vitamin D3; Dietary supplement: Drops with vitamin D3

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Drops with lactobacilli and vitamin D3; Oil suspension with lactobacilli and vitamin D3
Placebo Comparator: 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.	Dietary supplement: Drops with vitamin D3; Oil suspension with vitamin D3

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant sleep duration (min/day) on days 0, 7, 14, 21, 28	Infant sleep duration	7, 14, 21, 28 days
Change in maternal depression score from day 0 through day 28	Change in maternal depression score	28 days

Collaborators and Investigators

• Sponsor: Biocare Copenhagen A/S
• Collaborators: Lviv National Medical University
• Investigators: Study Director: Soren Thomsen, Biocare Copenhagen A/S

Study record dates

Study Major Dates

• Study Start: December 9, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: IC-SVG-P0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No