Infantile Colic
Conditions
Brief summary
Study type: Randomized controlled trial with two parallel arms Objectives Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as 1. the number of responders or the treatment success (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time \>50% in 3 weeks. (day 1 to day 21 of the study) 2. maternal depression and family functioning scoring
Detailed description
Inclusion criteria : * less then 12 weeks of age * term infant (≥ 38 weeks gestational age) * birth weight \> 2,500g * infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment. * parental motivation to postpone changes in the infant feeding mode, unless necessary Exclusion criteria: * birth weight less than 2500 g * failure to thrive * chronic illness or major medical problem * gastrointestinal disease * cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??) * use of any antibiotic or probiotic in the week (7 days) prior to enrollment * use of proton pump inhibitors in the week (7 days) prior to enrollment * if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment * infant receiving solid foods (such as cereals, mashed fruits or vegetable purée) * change of feeding mode planned by parents during the study period Randomization and blinding: to be written by the CRO, according to its own procedures. Extreme caution should be given to blinding. Methods should give full certainty that blinding was perfect at the subject (parent) level, but also at the pediatrician and with all involved personnel. Randomization should be done according to 3 feeding modes : * breast feeding: only breast, except for 2 bottle feedings a week, * formula fed: only formula except two breast feeding a week, * mixed feeding: all the remaining
Interventions
DIETARY_SUPPLEMENTNidina
DIETARY_SUPPLEMENTPlacebo
Sponsors
Antonio Di Mauro
Ruggiero Francavilla
Lorenzo Trovè
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria : * less then 12 weeks of age * term infant (≥ 38 weeks gestational age) * birth weight \> 2,500g * infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment. * parental motivation to postpone changes in the infant feeding mode, unles
Exclusion criteria
* \- birth weight less than 2500 g * failure to thrive * chronic illness or major medical problem * gastrointestinal disease * cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??) * use of any antibiotic or probiotic in the week (7 days) prior to enrollment * use of proton pump inhibitors in the week (7 days) prior to enrollment * if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment * 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 |
|---|---|---|
| Daily Crying duration | three days | The average crying time in minutes per day measured on day 19, 20, and 21 between active and placebo groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family functional score (family functioning scale) | one day | The score achieved in the family functioning scale at day 21. |
| Rate of success (decrease in mean daily crying time) | 3 days | Percentage of infants in the active group compared to the placebo group in whom the mean of daily crying time of the days 19, 20 and 21 decreased by 50% compared to the three days prior to recruitment. |
| Mother depression (mother depression Scale) | One day | The score achieved in the mother depression Scale at day 21. |
Countries
Italy
Contacts
Primary ContactFlavia Indrio, MD
Outcome results
None listed