Infant Colic
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDrops with vitamin D3
Oil suspension with vitamin D3
DIETARY_SUPPLEMENTDrops with lactobacilli and vitamin D3
Oil suspension with lactobacilli and vitamin D3
Sponsors
Lviv National Medical University
Biocare Copenhagen A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 12 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean cry/fuss time (min/day) from day 0 through day 28 | 28 days | Change in mean cry/fuss time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean cry time (min/day) from day 0 through day 28 | 28 days | Change in mean cry time |
| Change in mean fuss time (min/day) from day 0 through day 28 | 28 days | Change in mean fuss time |
| Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline | 7, 14, 21, 28 days | Outcome Measure Description |
| 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); | 7, 14, 21, 28 days | Recovery success |
| Cry and fuss time (min/day) on days 0, 7, 14, 21, 28 | 7, 14, 21, 28 days | Cry and fuss time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant sleep duration (min/day) on days 0, 7, 14, 21, 28 | 7, 14, 21, 28 days | Infant sleep duration |
| Change in maternal depression score from day 0 through day 28 | 28 days | Change in maternal depression score |
Outcome results
None listed