Lactocare Baby Drops in Infants Colic

Biocare Copenhagen A/S168 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

168

Conditions

Infant Colic

Interventions

Drops with lactobacilli and vitamin D3DIETARY_SUPPLEMENT

Oil suspension with lactobacilli and vitamin D3

Drops with vitamin D3DIETARY_SUPPLEMENT

Oil suspension with vitamin D3

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in mean cry/fuss time (min/day) from day 0 through day 28

Change in mean cry/fuss time

Time frame: 28 days

Secondary Outcomes

Change in mean cry time (min/day) from day 0 through day 28

Change in mean cry time

Time frame: 28 days

Change in mean fuss time (min/day) from day 0 through day 28

Change in mean fuss time

Time frame: 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

Time frame: 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

Time frame: 7, 14, 21, 28 days

Cry and fuss time (min/day) on days 0, 7, 14, 21, 28

Cry and fuss time

Time frame: 7, 14, 21, 28 days

Data from ClinicalTrials.gov

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