colic
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. The sample of the present study will be composed of infants who developed colic according to the Rome IV criteria, between 2 and
G07.203.300.456.500
Sponsors
Universidade Federal de Goiás
Cifarma ltda
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Infants with mothers aged 18 or over will be selected; infants aged between 2 and 12 completed weeks of life; born at term, with a birth weight of 2500 g or more; who present uncontrollable crying for at least 3 hours a day and 3 days a week for at least one week (according to the criteria of ROME IV)
Exclusion criteria
Exclusion criteria: Infants who were exposed to the use of probiotics before or during the study will be excluded; and/or who have gastroesophageal reflux disease using specific medication (proton pump and/or prokinetic inhibitors); and/or who have gastrointestinal tract malformations; and/or who need to use antibiotics during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a greater decrease between the mean initial and final crying time (day 28) in the group that received the probiotic compared to the placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find variations in the concentration of fecal calprotectin, through the stool samples collected at the beginning and end of the study, with lower levels in the placebo group;Evaluate the number of infants responding to the probiotic (infants who reduced at least 50% of crying time in minutes) when compared to the beginning of the intervention. The number of responders in the probiotic group is estimated to be significantly higher than the placebo group;Compare changes in the microbiota profile of the infant with colic. This will be verified by analyzing the infant's microbiota before and after the intervention using the 16S-RNA technique. significant differences between the groups are expected | — |
Countries
Brazil
Contacts
Public ContactSaskia Vaz
Universidade Federal de Goiás
Outcome results
None listed