Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

Colic, Infantile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03106285
• Other study ID #: CSUB0130
• Status: Withdrawn
• Phase: N/A
• Start date: April 14, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2022
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Colic, Infantile

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM17938
5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938
• Placebo
5 drops of placebo drops

Locations

Country	Name	City	State
Indonesia	Badriul Hegar	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia AB

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily average of crying time with L reuteri vs placebo	Daily crying diary	day 7
Primary	Daily average of crying time with L reuteri vs placebo	Daily crying diary	Day 14
Primary	Daily average of crying time with L reuteri vs placebo	Daily crying diary	Day 21
Primary	Daily average of crying time with L reuteri vs placebo	Daily crying diary	Day 28
Secondary	Number of responder vs non-responders	Daily crying	baseline, day 7, 14, 21, 28
Secondary	Reduction of daily average crying time	Daily crying	baseline, day 7, 14, 21, 28
Secondary	Parents perception of colic severity (Diary)	Diary	baseline, day 7, 14, 21, 28
Secondary	Parents/Family quality of life (Diary)	Diary	baseline, day 7, 14, 21, 28
Secondary	Parental satisfactory (Diary)	Diary	baseline, day 7, 14, 21, 28