Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT03477669
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 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.
Study:
NCT03477669
Study Brief:
Protocol Section:
NCT03477669