NCT01855269

Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study

A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Weeks – 3 Months
• Healthy volunteers: Not accepted

Summary

The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.

Detailed description

Infantile colic ıs one of the most common problems within the first 3 months of life, affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome characterized by paroxysmal, excessive, inconsolable crying without identifiable cause. Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data demonstrated safety after long-term dietary supplementation for newborn infants. The positive effects of this probiotic on intestinal disorders such as constipation and diarrhea and in protection from infection,as well as its capacity to modulate immune responses. The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.

Conditions

• Crying

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri	Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks
DIETARY_SUPPLEMENT	Herbal drop	Herbal drop containing sodium bicarbonate, Pimpinella anisum oil,foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks
DIETARY_SUPPLEMENT	placebo sterile water

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-02-01
• Completion: 2013-04-01
• First posted: 2013-05-16
• Last updated: 2013-05-16

Locations

1 site across 1 country: Turkey (Türkiye)