NCT03477669

Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants

Infantile Colic: A Prospective, Randomized, Double Blind, Placebo Controlled Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 3 Weeks – 16 Weeks
• Healthy volunteers: Not accepted

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 will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty subjects will be randomly assigned to each group for a total enrollment of 60 infants.

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 participants. Participants will be recruited from the Children's' Hospital \& Medical Center's Pediatrician's group. The study coordinators and Investigators will conduct informational lunches at selected pediatrician offices in the Omaha area. The investigators will introduce the topic of the colic study to participants seen for routine follow up who the investigators suspect may meet the diagnostic criteria for colic. The study coordinator will then contact the participants and assess suitability with a brief phone questionnaire. If participants appear to qualify and the participant is agreeable an enrollment appointment will be made to sign the consent, education on the product and how to administer it, teaching regarding diary instrument and completion of the quality of life survey. A brief medical history including the delivery mode and family allergy history will be collected as well as weight and length of the infant at the consent visit. A subset of participants will be asked to provide a stool sample for analysis of calprotectin level (a marker of intestinal inflammation) if the participants are willing to provide this. Participants will administer 5 drops of the study product once a day with a feeding at mid-day. Participants will be instructed to record crying time for a 1 week run in period and then administer the provided drops as directed once a day and record daily crying time on 3 days each week for 4 subsequent weeks. A follow up phone call 2 weeks after starting the product will be conducted to ensure compliance and assess for any adverse events. A final visit after 4 weeks will be conducted for collection of the diary data, completion of the quality of life survey, obtainment of the infant's length and weight and collection of a follow up stool sample if the provided one at baseline.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	chamomile/probiotic arm	Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
DIETARY_SUPPLEMENT	Placebo of chamomile/probiotic arm	Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.

Timeline

• Start date: 2018-05-18
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2018-03-26
• Last updated: 2023-08-25

Locations

1 site across 1 country: United States