Study Stopped
Cannot perform the study due to practical issues
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedStudy Start
First participant enrolled
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedMay 5, 2022
May 1, 2022
2 years
March 24, 2017
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Daily average of crying time with L reuteri vs placebo
Daily crying diary
day 7
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Day 14
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Day 21
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Day 28
Secondary Outcomes (5)
Number of responder vs non-responders
baseline, day 7, 14, 21, 28
Reduction of daily average crying time
baseline, day 7, 14, 21, 28
Parents perception of colic severity (Diary)
baseline, day 7, 14, 21, 28
Parents/Family quality of life (Diary)
baseline, day 7, 14, 21, 28
Parental satisfactory (Diary)
baseline, day 7, 14, 21, 28
Study Arms (2)
Lactobacillus reuteri DSM17938
EXPERIMENTALOil drops
Placebo
PLACEBO COMPARATOROils drops
Interventions
5 drops of active oil drops. The active dose consists of 10\^8 CFU L retueri DSM17938
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinically suspected allergy
- Consumption of probiotics, antibiotics, PPI
- Failure to thrive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioGaia ABlead
Study Sites (1)
Badriul Hegar
Jakarta, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Badriul Hegar, MD, PhD
RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2017
First Posted
April 10, 2017
Study Start
April 14, 2017
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
May 5, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share