Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
Primary Purpose
Colic, Infantile
Status
Withdrawn
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM17938
Placebo
Sponsored by
About this trial
This is an interventional other trial for Colic, Infantile
Eligibility Criteria
Inclusion Criteria:
- otherwise healthy infants
- Infantile colic according to Roe IV criteria
- Full term infants
- Birth weight 2500 - 4000g
- Exclusively breast milk or partially breastfed
- Mothers last education degree is Senior high school
Exclusion Criteria
- Clinically suspected allergy
- Consumption of probiotics, antibiotics, PPI
- Failure to thrive
Sites / Locations
- Badriul Hegar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lactobacillus reuteri DSM17938
Placebo
Arm Description
Oil drops
Oils drops
Outcomes
Primary Outcome Measures
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Secondary Outcome Measures
Number of responder vs non-responders
Daily crying
Reduction of daily average crying time
Daily crying
Parents perception of colic severity (Diary)
Diary
Parents/Family quality of life (Diary)
Diary
Parental satisfactory (Diary)
Diary
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03106285
Brief Title
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
Official Title
Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Cannot perform the study due to practical issues
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Detailed Description
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.
Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic, Infantile
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus reuteri DSM17938
Arm Type
Experimental
Arm Description
Oil drops
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oils drops
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM17938
Intervention Description
5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
5 drops of placebo drops
Primary Outcome Measure Information:
Title
Daily average of crying time with L reuteri vs placebo
Description
Daily crying diary
Time Frame
day 7
Title
Daily average of crying time with L reuteri vs placebo
Description
Daily crying diary
Time Frame
Day 14
Title
Daily average of crying time with L reuteri vs placebo
Description
Daily crying diary
Time Frame
Day 21
Title
Daily average of crying time with L reuteri vs placebo
Description
Daily crying diary
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of responder vs non-responders
Description
Daily crying
Time Frame
baseline, day 7, 14, 21, 28
Title
Reduction of daily average crying time
Description
Daily crying
Time Frame
baseline, day 7, 14, 21, 28
Title
Parents perception of colic severity (Diary)
Description
Diary
Time Frame
baseline, day 7, 14, 21, 28
Title
Parents/Family quality of life (Diary)
Description
Diary
Time Frame
baseline, day 7, 14, 21, 28
Title
Parental satisfactory (Diary)
Description
Diary
Time Frame
baseline, day 7, 14, 21, 28
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
otherwise healthy infants
Infantile colic according to Roe IV criteria
Full term infants
Birth weight 2500 - 4000g
Exclusively breast milk or partially breastfed
Mothers last education degree is Senior high school
Exclusion Criteria
Clinically suspected allergy
Consumption of probiotics, antibiotics, PPI
Failure to thrive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badriul Hegar, MD, PhD
Organizational Affiliation
RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Badriul Hegar
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
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