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| Name | Class |
|---|---|
| Lviv National Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drops with lactobacilli and vitamin D3 | Dietary Supplement | Oil suspension with lactobacilli and vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean cry/fuss time (min/day) from day 0 through day 28 | Change in mean cry/fuss time | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean cry time (min/day) from day 0 through day 28 | Change in mean cry time | 28 days |
| Change in mean fuss time (min/day) from day 0 through day 28 | Change in mean fuss time |
| Measure | Description | Time Frame |
|---|---|---|
| Infant sleep duration (min/day) on days 0, 7, 14, 21, 28 | Infant sleep duration | 7, 14, 21, 28 days |
| Change in maternal depression score from day 0 through day 28 | Change in maternal depression score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soren Thomsen | Biocare Copenhagen A/S | Study Director |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drops with vitamin D3 | Dietary Supplement | Oil suspension with vitamin D3 |
|
| 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 | 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 | 7, 14, 21, 28 days |
| Cry and fuss time (min/day) on days 0, 7, 14, 21, 28 | Cry and fuss time | 7, 14, 21, 28 days |
| 28 days |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |