Lactocare Baby Drops in Infants Colic

Infant Colic Clinical Trial

— LACONIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839239
• Other study ID #: IC-SVG-P0001
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: January 17, 2018
• Start date: December 9, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Biocare Copenhagen A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

Dietary Supplement:
• Drops with lactobacilli and vitamin D3
Oil suspension with lactobacilli and vitamin D3
• Drops with vitamin D3
Oil suspension with vitamin D3

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biocare Copenhagen A/S	Lviv National Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant sleep duration (min/day) on days 0, 7, 14, 21, 28	Infant sleep duration	7, 14, 21, 28 days
Other	Change in maternal depression score from day 0 through day 28	Change in maternal depression score	28 days
Primary	Change in mean cry/fuss time (min/day) from day 0 through day 28	Change in mean cry/fuss time	28 days
Secondary	Change in mean cry time (min/day) from day 0 through day 28	Change in mean cry time	28 days
Secondary	Change in mean fuss time (min/day) from day 0 through day 28	Change in mean fuss time	28 days
Secondary	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
Secondary	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
Secondary	Cry and fuss time (min/day) on days 0, 7, 14, 21, 28	Cry and fuss time	7, 14, 21, 28 days