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Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813772
Recruitment Status : Unknown
Verified September 2016 by Annamaria Staiano, Federico II University.
Recruitment status was:  Recruiting
First Posted : June 27, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Annamaria Staiano, Federico II University

Brief Summary:
Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The variability in the prevalence of IC reported by the several studies depends on different criteria used to define IC.The etiology of IC remains still unclear. Recently, the composition of intestinal microbiome has been addressed as an independent risk factor for IC. There are no uniform criteria for a specific therapeutic approach of IC. Based on these conclusions the objectives of our study are: to determine whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration and in prolonging the duration of sleeping period

Condition or disease Intervention/treatment Phase
Infant Colics Dietary Supplement: Milk formula NAN Sensitive, Nestle Dietary Supplement: Milk formula Optipro, Nestle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic: a Double Blind, Randomized-controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: group 1
Patients with infantile colics who will receive the milk formula NAN Sensitive, Nestlè
Dietary Supplement: Milk formula NAN Sensitive, Nestle
Infants randomized to group 1 will receive the milk formula NAN Sensitive, Nestle for a period of 4 weeks.

Active Comparator: group 2
Patients with infantile colics who will receive the milk formula NAN Optipro, Nestlè
Dietary Supplement: Milk formula Optipro, Nestle
Infants randomized to group 1 will receive the milk formula NAN Optipro, Nestle for a period of 4 weeks.




Primary Outcome Measures :
  1. whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration. [ Time Frame: 7, 14, 21, 28 days, 2 and 3 months ]
    Infant crying duration (minutes per day) at 7, 14, 21, 28 days, 2 and 3 months post-intervention.


Secondary Outcome Measures :
  1. whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration. [ Time Frame: 28 days ]
    Percentage of responders at 28 days post-intervention. A response to the treatment will be defined as 50% of reduction of infant crying.

  2. whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in increasing infant sleep. [ Time Frame: 7, 14, 21, 28 days, 2 and 3 months ]
    Longer infant sleep duration at 7, 14, 21, 28 days, 2 and 3 months post-intervention

  3. the effect of a partially hydrolyzed formula (pHF) on quality of life of the enrolled patients [ Time Frame: 3 months ]
    Reduction of mean scores of a standardized measure for childrens' quality of life

  4. the effect of a partially hydrolyzed formula (pHF) on quality of life of parents [ Time Frame: 3 months ]
    Reduction of mean scores of a standardized measure for parents' quality of life

  5. the effect of this infant formula enriched with Lactobacillus reuteri on fecal microbiome of colicky infants [ Time Frame: 2 months ]
    Changes in gut microbiome

  6. Changes in stool frequency and consistency [ Time Frame: 28 days ]
    Changes in stool frequency and consistency

  7. Parental perception of colic severity (VAS 0-10) [ Time Frame: 28 days ]
    Parental perception of colic severity (VAS 0-10)

  8. Parental perception of sleep quality (VAS 0-10) [ Time Frame: 28 days ]
    Parental perception of sleep quality (VAS 0-10)



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Full-term infants (≥37 weeks gestation at birth); Exclusively formula fed infants at time of enrolment; Infants suffering from IC according to Rome III criteria (Appendix 1); Age < 4 months of life; 5-minute Apgar score ≥7; Birth weight ≥2500 g.

Exclusion Criteria:

Consumption of formula containing probiotics, pHF or with reduced lactose content at time of enrolment; Major medical problem or acute illness, including gastroesophageal reflux, cow's milk protein allergy History of antibiotic treatment before or during the study; History of probiotic or L reuteri supplementation; History of any allergies to any of the ingredients in the probiotic L reuteri Concurrent participation in another clinical trial. Birth weight < 2500 g; Failed to thrive; Breastfed infants; NAN (to avoid the formula switch effect).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813772


Contacts
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Contact: Annamaria Staiano staiano@unina.it

Locations
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Italy
Annamaria Staiano Recruiting
Naples, Italy, 80131
Contact: Annamaria Staiano       staiano@unina.it   
Sponsors and Collaborators
Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annamaria Staiano, Professor of Pediatrics, Federico II University
ClinicalTrials.gov Identifier: NCT02813772    
Other Study ID Numbers: 30/05/2016
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: December 2016
Keywords provided by Annamaria Staiano, Federico II University:
infants
colic
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases