Colic, Infantile
Conditions
Brief summary
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Detailed description
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown. Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri DSM17938
5 drops of active oil drops. The active dose consists of 10\^8 CFU L retueri DSM17938
DIETARY_SUPPLEMENTPlacebo
5 drops of placebo drops
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
* otherwise healthy infants * Infantile colic according to Roe IV criteria * Full term infants * Birth weight 2500 - 4000g * Exclusively breast milk or partially breastfed * Mothers last education degree is Senior high school
Exclusion criteria
* Clinically suspected allergy * Consumption of probiotics, antibiotics, PPI * Failure to thrive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily average of crying time with L reuteri vs placebo | day 7 | Daily crying diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of responder vs non-responders | baseline, day 7, 14, 21, 28 | Daily crying |
| Reduction of daily average crying time | baseline, day 7, 14, 21, 28 | Daily crying |
| Parents perception of colic severity (Diary) | baseline, day 7, 14, 21, 28 | Diary |
| Parents/Family quality of life (Diary) | baseline, day 7, 14, 21, 28 | Diary |
| Parental satisfactory (Diary) | baseline, day 7, 14, 21, 28 | Diary |
Countries
Indonesia
Outcome results
None listed