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

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ClinicalTrials.gov Identifier: NCT01855269
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Crying Dietary Supplement: Lactobacillus reuteri Dietary Supplement: Herbal drop Dietary Supplement: placebo sterile water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
Study Start Date : April 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
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
Other Name: Biogaia

Active Comparator: 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
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
Other Name: Babs

Placebo Comparator: Sterile water
Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks
Dietary Supplement: placebo sterile water



Primary Outcome Measures :
  1. Crying time [ Time Frame: 3 weeks ]
    Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855269


Locations
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Turkey
Sami Ulus CH
Ankara, Turkey, 06120
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Principal Investigator: Nilgün Karadağ, MD MD, Sami Ulus CH
Publications of Results:
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Responsible Party: Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01855269    
Other Study ID Numbers: 134/Feb 2012
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Keywords provided by Dilek Dilli, Dr. Sami Ulus Children's Hospital:
probiotic
infantile colic
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases