Lactocare Baby Drops in Infants Colic

NCT ID: NCT02839239

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-09
• Study Completion Date: 2018-01-15

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.

Conditions

Infant Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Drops with lactobacilli and vitamin D3

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.

Group Type: EXPERIMENTAL

Drops with lactobacilli and vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Oil suspension with lactobacilli and vitamin D3

Drops with vitamin D3

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.

Group Type: PLACEBO_COMPARATOR

Drops with vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Oil suspension with vitamin D3

Interventions

Drops with lactobacilli and vitamin D3

Oil suspension with lactobacilli and vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Drops with vitamin D3

Oil suspension with vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lviv National Medical University

OTHER

Sponsor Role: collaborator

Biocare Copenhagen A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soren Thomsen

Role: STUDY_DIRECTOR

Biocare Copenhagen A/S

Other Identifiers

IC-SVG-P0001

Identifier Type: -

Identifier Source: org_study_id