Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

May 2, 2022 updated by: BioGaia AB

Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic

This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus reuteri DSM17938
Oil drops
Dietary supplement: Lactobacillus reuteri DSM17938
5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938
Placebo Comparator: Placebo
Oils drops
Dietary supplement: Placebo
5 drops of placebo drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily average of crying time with L reuteri vs placebo
Time Frame: day 7
Daily crying diary
day 7
Daily average of crying time with L reuteri vs placebo
Time Frame: Day 14
Daily crying diary
Day 14
Daily average of crying time with L reuteri vs placebo
Time Frame: Day 21
Daily crying diary
Day 21
Daily average of crying time with L reuteri vs placebo
Time Frame: Day 28
Daily crying diary
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responder vs non-responders
Time Frame: baseline, day 7, 14, 21, 28
Daily crying
baseline, day 7, 14, 21, 28
Reduction of daily average crying time
Time Frame: baseline, day 7, 14, 21, 28
Daily crying
baseline, day 7, 14, 21, 28
Parents perception of colic severity (Diary)
Time Frame: baseline, day 7, 14, 21, 28
Diary
baseline, day 7, 14, 21, 28
Parents/Family quality of life (Diary)
Time Frame: baseline, day 7, 14, 21, 28
Diary
baseline, day 7, 14, 21, 28
Parental satisfactory (Diary)
Time Frame: baseline, day 7, 14, 21, 28
Diary
baseline, day 7, 14, 21, 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioGaia AB

Investigators

  • Principal Investigator: Badriul Hegar, MD, PhD, RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSUB0130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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