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

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

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.

Study Overview

• Status: Terminated
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: chamomile/probiotic arm; Dietary supplement: Placebo of chamomile/probiotic arm

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital & Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 3 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chamomile/probiotic arm; Infant will receive 5 drops of the study product once per day with a feeding at midday.	Dietary supplement: chamomile/probiotic arm; Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
Placebo Comparator: Placebo of chamomile/probiotic arm; Infant will receive 5 drops of a placebo product once a day at midday.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying time	The investigators will be comparing time on the Baby's Day Diary © from the 1 week run-in to the end of the 4 week period and hope to see a 50% drop in crying time listed on the Baby's Day Diary© .	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life-The Short Form -36 (SF-36)	Measurement of QOL scores before and after treatment with the drops. The investigators hope to see an improvement in the participants Qualify of Life scores over the 4 week study.	4 weeks
Calprotectin levels	The investigators hope to see a significant decrease in the baby's calprotectin stool levels.	4 weeks

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: iHealth
• Investigators: Principal Investigator: Ruben E Quiros, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Colic
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 0060-18-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No