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

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:

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

Study Overview

• Status: Unknown
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Nidina

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Flavia Indrio, MD; Email: f.indrio@alice.it

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • University of Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reuteri group; Milk formula added with probiotic L reuterii DSM 17938	Dietary supplement: Nidina
Placebo Comparator: Placebo; Milk formula without probiotic L reuterii DSM 17938	Dietary supplement: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bari
• Collaborators: Antonio Di Mauro; Ruggiero Francavilla; Lorenzo Trovè
• Investigators: Principal Investigator: Flavia Indrio, MD, University of Bari

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: VF/FC