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

April 28, 2015 updated by: Flavia Indrio, University of Bari

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily Crying duration
Time Frame: three days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of success (decrease in mean daily crying time)
Time Frame: 3 days
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)
Time Frame: one day
The score achieved in the family functioning scale at day 21.
one day
Mother depression (mother depression Scale)
Time Frame: One day
The score achieved in the mother depression Scale at day 21.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bari

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Antonio Di Mauro
Ruggiero Francavilla
Lorenzo Trovè

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Flavia Indrio, MD, University of Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VF/FC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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