Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study
A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedMay 16, 2013
May 1, 2013
10 months
May 13, 2013
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Crying time
Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks
3 weeks
Secondary Outcomes (1)
postpartum depression
3 weeks
Study Arms (3)
Lactobacillus reuteri
ACTIVE COMPARATORLactobacillus 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 COMPARATORHerbal 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 COMPARATORSterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks
Interventions
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- chronic illness
- gastrointestinal disorders
- infants received either antibiotics or probiotics in the previous week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sami Ulus CH
Ankara, Turkey, 06120, Turkey (Türkiye)
Related Publications (1)
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: 17200238RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilgün Karadağ, MD
MD, Sami Ulus CH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 16, 2013
Study Start
April 1, 2012
Primary Completion
February 1, 2013
Study Completion
April 1, 2013
Last Updated
May 16, 2013
Record last verified: 2013-05