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

Primary Purpose

Crying

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lactobacillus reuteri
Herbal drop
placebo sterile water
Sponsored by
Dr. Sami Ulus Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Crying focused on measuring probiotic, infantile colic

Eligibility Criteria

3 Weeks - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sami Ulus CH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lactobacillus reuteri

Herbal drop

Sterile water

Arm Description

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

Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 13, 2013
Last Updated
May 15, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01855269
Brief Title
Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study
Official Title
A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crying
Keywords
probiotic, infantile colic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri
Arm Type
Active Comparator
Arm Description
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
Arm Title
Herbal drop
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sterile water
Arm Type
Placebo Comparator
Arm Description
Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Other Intervention Name(s)
Biogaia
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Herbal drop
Other Intervention Name(s)
Babs
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo sterile water
Primary Outcome Measure Information:
Title
Crying time
Description
Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
postpartum depression
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilgün Karadağ, MD
Organizational Affiliation
MD, Sami Ulus CH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sami Ulus CH
City
Ankara
ZIP/Postal Code
06120
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
17200238
Citation
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.
Results Reference
result

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

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