Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

BioGaia

Status: Withdrawn

Conditions: Colic, Infantile

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus reuteri DSM17938

Study type: Interventional

Funder types: Industry

Identifiers

NCT03106285

CSUB0130

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri DSM17938

Experimental group

Description:

Oil drops

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM17938

Placebo

Placebo Comparator group

Description:

Oils drops

Treatment:

Dietary Supplement: Placebo