Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

Not Applicable

Withdrawn

• Conditions: Colic, Infantile
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM17938; Dietary Supplement: Placebo

• Registration Number: NCT03106285
• Lead Sponsor: BioGaia AB

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.

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-10
• Study Start: 2017-04-14
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri DSM17938	Lactobacillus reuteri DSM17938	Oil drops
Placebo	Placebo	Oils drops

Primary Outcome Measures

Name	Time	Method
Daily average of crying time with L reuteri vs placebo	Day 28	Daily crying diary

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Badriul Hegar; 🇮🇩 Jakarta, Indonesia