Back to resultsLactocare Baby Drops in Infants Colic (LACONIC)
Primary Purpose
Infant Colic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drops with lactobacilli and vitamin D3
Drops with vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Infant Colic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drops with lactobacilli and vitamin D3
Drops with vitamin D3
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in mean cry/fuss time (min/day) from day 0 through day 28
Change in mean cry/fuss time
Secondary Outcome Measures
Change in mean cry time (min/day) from day 0 through day 28
Change in mean cry time
Change in mean fuss time (min/day) from day 0 through day 28
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
Outcome Measure Description
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
Cry and fuss time (min/day) on days 0, 7, 14, 21, 28
Cry and fuss time
Full Information
NCT ID
NCT02839239
First Posted
July 18, 2016
Last Updated
January 17, 2018
Sponsor
Biocare Copenhagen A/S
Collaborators
Lviv National Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02839239
Brief Title
Lactocare Baby Drops in Infants Colic
Acronym
LACONIC
Official Title
Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 9, 2016 (undefined)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocare Copenhagen A/S
Collaborators
Lviv National Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drops with lactobacilli and vitamin D3
Arm Type
Experimental
Arm Description
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.
Arm Title
Drops with vitamin D3
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Drops with lactobacilli and vitamin D3
Intervention Description
Oil suspension with lactobacilli and vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Drops with vitamin D3
Intervention Description
Oil suspension with vitamin D3
Primary Outcome Measure Information:
Title
Change in mean cry/fuss time (min/day) from day 0 through day 28
Description
Change in mean cry/fuss time
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change in mean cry time (min/day) from day 0 through day 28
Description
Change in mean cry time
Time Frame
28 days
Title
Change in mean fuss time (min/day) from day 0 through day 28
Description
Change in mean fuss time
Time Frame
28 days
Title
Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline
Description
Outcome Measure Description
Time Frame
7, 14, 21, 28 days
Title
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);
Description
Recovery success
Time Frame
7, 14, 21, 28 days
Title
Cry and fuss time (min/day) on days 0, 7, 14, 21, 28
Description
Cry and fuss time
Time Frame
7, 14, 21, 28 days
Other Pre-specified Outcome Measures:
Title
Infant sleep duration (min/day) on days 0, 7, 14, 21, 28
Description
Infant sleep duration
Time Frame
7, 14, 21, 28 days
Title
Change in maternal depression score from day 0 through day 28
Description
Change in maternal depression score
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Thomsen
Organizational Affiliation
Biocare Copenhagen A/S
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Lactocare Baby Drops in Infants Colic
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