Clinical trial NCT02839239: Lactocare Baby Drops in Infants Colic
Official title: Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Colic
Lead sponsor: Biocare Copenhagen A/S
Sponsor class: INDUSTRY
Collaborators: name: Lviv National Medical University
First posted: 2016-07-20
Enrollment: 168
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean cry/fuss time (min/day) from day 0 through day 28
timeFrame: 28 days
Secondary outcomes:
measure: Change in mean cry time (min/day) from day 0 through day 28
timeFrame: 28 days
measure: Change in mean fuss time (min/day) from day 0 through day 28
timeFrame: 28 days
measure: Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline
timeFrame: 7, 14, 21, 28 days
measure: 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);
timeFrame: 7, 14, 21, 28 days
measure: Cry and fuss time (min/day) on days 0, 7, 14, 21, 28
timeFrame: 7, 14, 21, 28 days
Other outcomes:
measure: Infant sleep duration (min/day) on days 0, 7, 14, 21, 28
timeFrame: 7, 14, 21, 28 days
measure: Change in maternal depression score from day 0 through day 28
timeFrame: 28 days
Locations:
Study officials:
affiliation: Biocare Copenhagen A/S
name: Soren Thomsen
role: STUDY_DIRECTOR
References: