Infantile Colic
Conditions
Brief summary
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)
Detailed description
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21
Interventions
DIETARY_SUPPLEMENTL. reuteri DSM 17938 in drops
L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
OTHERPlacebo
The placebo consists of an identical formulation except that the L. reuteri is not present
Sponsors
BioGaia AB
Innovacion y Desarrollo de Estrategias en Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Children allocated on different arms will receive drops of probiotics or placebo. Both product are identical in appearence and flavor
Intervention model description
Randomized controlled trial, double blind allocation concealment
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 9 Weeks
Healthy volunteers
No
Inclusion criteria
* Younger than 10 weeks of age * Full term infant (37-42 weeks gestational age) * Birth weight ≥ 2,500g * Apgar score ≥ 7 at 5 minutes * Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment) * Parental motivation to postpone changes in the infant feeding mode, unless necessary * Stated availability throughout the study period * Parent(s) willingness and ability to fill out charts and questionnaires * Signed informed consent
Exclusion criteria
* Failure to thrive * Chronic illness or major medical problem * Gastrointestinal disease * Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial * Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1 * Use of proton pump inhibitors in the week (7 days) prior to enrolment * If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period * Use of infant formula with hydrolysed protein * Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée) * Change of feeding mode planned by parents during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crying time | 21 days | Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary crying time | Day 7 and 14 | Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group |
| Crying and fussing | 7,14 and 21 days | Average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group |
| Total responders | 7,14 and 21 days | Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study |
| Impact on Quality of Life | 7, 14 and 21 days | Impact on Quality of Life measured by PedsQL-2.0-Family Impact Module AU2.0 spa-MX. Changes from baseline to days 7, 14 and 21 |
| Maternal depression | 7, 14 and 21 days | Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS) |
Countries
Mexico
Contacts
Primary ContactPatricia Vidal, MSc
Backup ContactMonica Rodriguez, MSc
Outcome results
None listed