Back to resultsImpact of Probiotic Preparation VSL#3 on Infants Colics
Primary Purpose
Infant Colics
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
VSL#3 drops
VSL#3 drops placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infant Colics focused on measuring colics
Eligibility Criteria
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.
Sites / Locations
- Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
VSL#3 drops
VSL#3 drops placebo
Arm Description
31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
Outcomes
Primary Outcome Measures
Improvement of colics symptoms
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
Secondary Outcome Measures
Difference in the daily average crying time between end of treatment and baseline.
Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01869426
Brief Title
Impact of Probiotic Preparation VSL#3 on Infants Colics
Official Title
Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Colics
Keywords
colics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VSL#3 drops
Arm Type
Active Comparator
Arm Description
31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
Arm Title
VSL#3 drops placebo
Arm Type
Placebo Comparator
Arm Description
31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL#3 drops
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL#3 drops placebo
Primary Outcome Measure Information:
Title
Improvement of colics symptoms
Description
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Difference in the daily average crying time between end of treatment and baseline.
Description
Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariella Baldassarre, PhD
Organizational Affiliation
Policlinico Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Elisabetta Baldassarre, PhD
Phone
+393296114818
Email
mariellabaldassarre@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Elisabetta Baldassarre, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
29439395
Citation
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):195. doi: 10.3390/nu10020195.
Results Reference
derived
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Impact of Probiotic Preparation VSL#3 on Infants Colics
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