Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old

Study Overview
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Brief Summary
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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 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) maternal depression and family functioning scoring

Detailed Description
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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

Official Title
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Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old

Conditions
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Infantile Colic

Intervention / Treatment
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* Dietary Supplement: Nidina
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reuteri group<br>Milk formula added with probiotic L reuterii DSM 17938 | Dietary Supplement: Nidina<br> <br> |
| Placebo Comparator: Placebo<br>Milk formula without probiotic L reuterii DSM 17938 | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Crying duration | The average crying time in minutes per day measured on day 19, 20, and 21 between active and placebo groups. | three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of success (decrease in mean daily crying time) | 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. | 3 days | 
| Family functional score (family functioning scale) | The score achieved in the family functioning scale at day 21. | one day | 
| Mother depression (mother depression Scale) | The score achieved in the mother depression Scale at day 21. | One day |