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

NCT02430831 | Unknown Phase 4

• 1 other identifier: VF/FC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 2.maternal depression and family functioning scoring

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of success (decrease in mean daily crying time)

  3 days

• Family functional score (family functioning scale)

  one day

• Mother depression (mother depression Scale)

  One day

Study Arms (2)

Reuteri group

ACTIVE COMPARATOR

Milk formula added with probiotic L reuterii DSM 17938

Dietary Supplement: Nidina

Placebo

PLACEBO COMPARATOR

Milk formula without probiotic L reuterii DSM 17938

Dietary Supplement: Placebo

Interventions

Nidina DIETARY_SUPPLEMENT

Reuteri group

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: Up to 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- birth weight less than 2500 g
• failure to thrive
• chronic illness or major medical problem
• gastrointestinal disease
• 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

Sponsors & Collaborators

• University of Bari: lead
• Antonio Di Mauro: collaborator
• Ruggiero Francavilla: collaborator
• Lorenzo Trovè: collaborator

Study Sites (1)

University of Bari

Bari, BA, 70124, Italy

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Flavia Indrio, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia Indrio, MD

CONTACT

f.indrio@alice.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 30, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

IT (1)