Clinical trial NCT02430831: Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
Official title: Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infantile Colic
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: Antonio Di Mauro
name: Ruggiero Francavilla
name: Lorenzo Trovè
First posted: 2015-04-30
Enrollment: 60
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Daily Crying duration
timeFrame: three days
Secondary outcomes:
measure: Rate of success (decrease in mean daily crying time)
timeFrame: 3 days
measure: Family functional score (family functioning scale)
timeFrame: one day
measure: Mother depression (mother depression Scale)
timeFrame: One day
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
state: BA
Study officials:
affiliation: University of Bari
name: Flavia Indrio, MD
role: PRINCIPAL_INVESTIGATOR
References: