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

NCT01855269 — Not applicable, Completed, 74 participants, Dr. Sami Ulus Children's Hospital

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

Registry	NCT01855269
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	74 (Actual)
Sponsor	Dr. Sami Ulus Children's Hospital (Other)
Conditions	Crying
Interventions	Lactobacillus reuteri, Herbal drop, placebo sterile water (Dietary supplement)
Dates	start 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 in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Lactobacillus reuteri	Active comparator	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	Active comparator	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
Sterile water	Placebo comparator	Dietary Supplement: placebo sterile water	Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks

Lactobacillus reuteri (Dietary supplement), also known as Biogaia: 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 (Dietary supplement), also known as Babs: 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 (Dietary supplement)

+Outcome measures

Primary outcomes

Crying time [3 weeks]: Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 3 Weeks to 3 Months

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

+Locations (1)

Facility	City	Country	Status
Sami Ulus CH	Ankara, Turkey	Turkey (Türkiye)

+Publications

Results publication: 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. doi: 10.1542/peds.2006-1222. PMID 17200238

+Investigators

Nilgün Karadağ, MD, Principal investigator, MD, Sami Ulus CH