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

Infantile Colic Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02430831
• Other study ID #: VF/FC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: April 28, 2015
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2015
• Source: University of Bari
• Contact: Flavia Indrio, MD
• Email: f.indrio[@]alice.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Dietary Supplement:
• Nidina

• Placebo

Locations

Country	Name	City	State
Italy	University of Bari	Bari	BA

Sponsors (4)

Lead Sponsor	Collaborator
University of Bari	Antonio Di Mauro, Lorenzo Trovè, Ruggiero Francavilla

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Family functional score (family functioning scale)	The score achieved in the family functioning scale at day 21.	one day	Yes
Secondary	Mother depression (mother depression Scale)	The score achieved in the mother depression Scale at day 21.	One day	Yes