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Completed

NCT Number: NCT01855269

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

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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Key information

Age range

3 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sami Ulus CH

Ankara, Turkey, 06120, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

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

Other names: Biogaia

Herbal drop

Dietary Supplement

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

Other names: Babs

placebo sterile water

Dietary Supplement

Primary outcomes

  1. Crying time

    Time frame: 3 weeks

    Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks

Secondary outcomes

  1. postpartum depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2013
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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