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

Crying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855269
• Other study ID #: 134/Feb 2012
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 15, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Dr. Sami Ulus Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colic
• Crying

Intervention

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
• 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
• placebo sterile water

Locations

Country	Name	City	State
Turkey	Sami Ulus CH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying time	Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks	3 weeks	No
Secondary	postpartum depression	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.	3 weeks	No