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The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.
Infantile colic ıs one of the most common problems within the first 3 months of life, affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome characterized by paroxysmal, excessive, inconsolable crying without identifiable cause. Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data demonstrated safety after long-term dietary supplementation for newborn infants. The positive effects of this probiotic on intestinal disorders such as constipation and diarrhea and in protection from infection,as well as its capacity to modulate immune responses.
The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri | Active Comparator | Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks |
|
| Herbal drop | Active Comparator | Herbal drop containing sodium bicarbonate, Pimpinella anisum oil, foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks |
|
| Sterile water | Placebo Comparator | Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Crying time | Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| postpartum depression | Emotional structures of mother's behaviour were evaluated before and at 2nd month with Edinburgh postpartum depression scale (EPDS), State Trait Anxiety Inventory (STAI) tests. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilgün Karadağ, MD | MD, Sami Ulus CH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sami Ulus CH | Ankara | Turkey | 06120 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17200238 | Result | Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222. |
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| ID | Term |
|---|---|
| D003448 | Crying |
| D003085 | Colic |
| ID | Term |
|---|---|
| D009633 | Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |
| D007232 | Infant, Newborn, Diseases |
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|
| Herbal drop | Dietary Supplement | Herbal drop containing sodium bicarbonate, Pimpinella anisum oil,foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks |
|
|
| placebo sterile water | Dietary Supplement |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |