Status:
TERMINATED
Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
Lead Sponsor:
University of Nebraska
Conditions:
Infantile Colic
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study wi...
Detailed Description
The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty participants will be randomly assigned to each group for a total enrollment of 60 partici...
Eligibility Criteria
Inclusion
- Caregiver is able to give written informed assent and willingness to participate in the study and comply with its procedures
- Male or Female
- Born at term (38-41 weeks gestation)
- Aged 3 wks-16 wks
- Be in generally good health as determined by the investigators
- BMI between 5th and 95th percentiles
- Exclusively breastfeeding throughout the study
- Be willing to complete crying diary
- Be willing to administer the probiotic as prescribed
- Be willing to completed the Quality of Life instrument before and after the intervention
- Meets the Rome criteria for colic
Exclusion
- Are less than 3 weeks or greater than 17 weeks of age or older
- Underweighted or obese based on BMI. Less than 5th or greater than 95th percentiles
- Mothers on an exclusively vegan diet and those with a chronic disease requiring medication therapy
- Mothers or infants having a significant acute or chronic existing illness \[cardiovascular, gastrointestinal, immunological\] or a condition, which in the investigators judgment contraindicates involvement in the study
- Mothers or infants having a condition or taking a medication, dietary supplement or food product that the investigator believes would interfere with the objectives of the study pose a safety risk or confound the interpretation of the study results
- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial
- Mothers or infants who are receiving treatment involving experimental drugs
- Participation in a recent experimental trial less than 30 days prior to this study
- Inability to complete the diary, survey scales and appointments
- First degree relative allergic to ragweed, asters, or chrysanthemums
- The following concomitant medications are not allowed at any time during or 1 week prior to initiation of the study: antibiotics or probiotics
Key Trial Info
Start Date :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03477669
Start Date
May 18 2018
End Date
February 25 2019
Last Update
August 25 2023
Active Locations (1)
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1
Children's Hospital & Medical Center
Omaha, Nebraska, United States, 68114