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Impact of Probiotic Preparation VSL#3 on Infants Colics

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ClinicalTrials.gov Identifier: NCT01869426
Recruitment Status : Unknown
Verified April 2015 by Prof. Maria Elisabetta Baldassarre, Policlinico Hospital.
Recruitment status was:  Recruiting
First Posted : June 5, 2013
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
Improvement of colics symptoms [ Time Frame: 3 weeks ]
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01869426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
Difference in the daily average crying time between end of treatment and baseline. [ Time Frame: 3 weeks ]
Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Probiotic Preparation VSL#3 on Infants Colics
Official Title  ICMJE Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
Brief Summary

Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians.

It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.

Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

Detailed Description

Aim of the study is to evaluate the improvement of colics symptoms by the oral administration of VSL#3 and the difference in the daily average crying time (measured with parental diary) between end of treatment and baseline.

In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or Placebo according to randomization list. The study product will be supplied as a box containing the oil bottle and a powder stick. The product should be stored refrigerated. On the first day of supplementation, the mother will open the sachet, pour the contents into the bottle and shake vigorously. A dropper is provided to count the drops. The suspension must be shaken vigorously before every use. Compliance will be monitored by filling out a diary.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infant Colics
Intervention  ICMJE
  • Dietary Supplement: VSL#3 drops
  • Dietary Supplement: VSL#3 drops placebo
Study Arms  ICMJE
  • Active Comparator: VSL#3 drops
    31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
    Intervention: Dietary Supplement: VSL#3 drops
  • Placebo Comparator: VSL#3 drops placebo
    31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
    Intervention: Dietary Supplement: VSL#3 drops placebo
Publications * Baldassarre ME, Di Mauro A, Tafuri S, Rizzo V, Gallone MS, Mastromarino P, Capobianco D, Laghi L, Zhu C, Capozza M, Laforgia N. Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Nutrients. 2018 Feb 10;10(2). pii: E195. doi: 10.3390/nu10020195.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 31, 2013)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants aged between 30 and 90 days
  • Breast fed exclusively during length of trial
  • Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
  • Debut of colic symptoms 6+/-1 days before randomization
  • Written informed consent from one or both parents
  • Stated availability and reliability throughout the study period.

Exclusion Criteria:

  • Major chronic disease
  • Gastrointestinal disease
  • Administration of antibiotics the week before randomization
  • Administration of probiotics two weeks before randomization
  • Infants with GI malformation, cystic fibrosis, other genetic diseases
  • Participation in other clinical trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01869426
Other Study ID Numbers  ICMJE VSLcolics13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
Study Sponsor  ICMJE Policlinico Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariella Baldassarre, PhD Policlinico Hospital
PRS Account Policlinico Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP