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

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Crying

Treatments: Dietary Supplement: placebo sterile water; Dietary Supplement: Herbal drop; Dietary Supplement: Lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT01855269

134/Feb 2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 3 weeks to 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 3 patient groups, including a placebo group

Lactobacillus reuteri

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus reuteri

Herbal drop

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Herbal drop

Sterile water

Placebo Comparator group

Description:

Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks

Treatment:

Dietary Supplement: placebo sterile water