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

Not Applicable

Completed

• Conditions: Crying
• Interventions: Dietary Supplement: Lactobacillus reuteri; Dietary Supplement: Herbal drop; Dietary Supplement: placebo sterile water

• Registration Number: NCT01855269
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-02
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Study First Posted: 2013-05-16
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• infants three weeks to three months
• infants with colic three hours of crying on three days in the week
• infants feeding with breast milk
• infants weighing 2500 to 4000 gram

Exclusion Criteria

• chronic illness
• gastrointestinal disorders
• infants received either antibiotics or probiotics in the previous week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri	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
Herbal drop	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
Sterile water	placebo sterile water	Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks

Primary Outcome Measures

Name	Time	Method
Crying time	3 weeks	Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks

Secondary Outcome Measures

Name	Time	Method
postpartum depression	3 weeks	Emotional structures of mother's behaviour were evaluated before and at 2nd month with Edinburgh postpartum depression scale (EPDS), State Trait Anxiety Inventory (STAI) tests.

Trial Locations

Locations (1)

Sami Ulus CH; 🇹🇷 Ankara, Turkey