Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
NCT ID: NCT02430831
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2015-05-31
2016-05-31
Brief Summary
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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
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Reuteri group
Milk formula added with probiotic L reuterii DSM 17938
Nidina
Placebo
Milk formula without probiotic L reuterii DSM 17938
Placebo
Interventions
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Nidina
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Weeks
ALL
No
Sponsors
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Antonio Di Mauro
UNKNOWN
Ruggiero Francavilla
UNKNOWN
Lorenzo Trovè
UNKNOWN
University of Bari
OTHER
Responsible Party
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Flavia Indrio
MD
Principal Investigators
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Flavia Indrio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bari
Locations
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University of Bari
Bari, BA, Italy
Countries
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Central Contacts
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Other Identifiers
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VF/FC
Identifier Type: -
Identifier Source: org_study_id