Trial | NCT02839239  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    168
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
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 Started
Dec 09
2016
Primary Completion
Jan 15
2018
Study Completion
Jan 15
2018
Last Update
Jan 18
2018

Dietary Supplement Drops with lactobacilli and vitamin D3

Oil suspension with lactobacilli and vitamin D3

Dietary Supplement Drops with vitamin D3

Oil suspension with vitamin D3

Drops with lactobacilli and vitamin D3 Experimental

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.

Drops with vitamin D3 Placebo Comparator

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.

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.
No Results Posted