Crying
Conditions
Keywords
probiotic, infantile colic
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri
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
DIETARY_SUPPLEMENTHerbal drop
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
DIETARY_SUPPLEMENTplacebo sterile water
Sponsors
Dr. Sami Ulus Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 3 Months
Healthy volunteers
No
Inclusion criteria
* infants three weeks to three months * infants with colic three hours of crying on three days in the week * infants feeding with breast milk * infants weighing 2500 to 4000 gram
Exclusion criteria
* chronic illness * gastrointestinal disorders * infants received either antibiotics or probiotics in the previous week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crying time | 3 weeks | Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postpartum depression | 3 weeks | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed