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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crying

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Dietary Supplement: Herbal drop
* Dietary Supplement: placebo sterile water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri<br>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: Lactobacillus reuteri<br>* 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<br>* Other names: Biogaia;|
| Active Comparator: Herbal drop<br>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: Herbal drop<br>* 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<br>* Other names: Babs;|
| Placebo Comparator: Sterile water<br>Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks | Dietary Supplement: placebo sterile water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crying time | Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, infantile colic