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

• ClinicalTrials.gov Identifier: NCT03477669
• Recruitment Status: Terminated
• First Posted: March 26, 2018
• Last Update Posted: May 9, 2019
• Sponsor: University of Nebraska
• Collaborator: iHealth
• Information provided by (Responsible Party): Ruben Quiros MD, University of Nebraska

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infantile Colic	Dietary Supplement: chamomile/probiotic arm; Dietary Supplement: Placebo of chamomile/probiotic arm	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double-blinded
• Primary Purpose: Treatment
• Official Title: Infantile Colic: A Prospective, Randomized, Double Blind, Placebo Controlled Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
• Actual Study Start Date: May 18, 2018
• Actual Primary Completion Date: February 25, 2019
• Actual Study Completion Date: February 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Crying time [ Time Frame: 4 weeks ]
   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© .

Secondary Outcome Measures :

1. Quality of Life-The Short Form -36 (SF-36) [ Time Frame: 4 weeks ]
   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.
2. Calprotectin levels [ Time Frame: 4 weeks ]
   The investigators hope to see a significant decrease in the baby's calprotectin stool levels.

Eligibility Criteria

• Ages Eligible for Study: up to 16 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Nebraska

Children's Hospital & Medical Center

Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

University of Nebraska

iHealth

Investigators

• Principal Investigator: Ruben E Quiros, MD; University of Nebraska

More Information

• Responsible Party: Ruben Quiros MD, Chief, Division of Pediatric Gastroenterology, University of Nebraska
• ClinicalTrials.gov Identifier: NCT03477669
• Other Study ID Numbers: 060-18-FB
• First Posted: March 26, 2018
• Last Update Posted: May 9, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ruben Quiros MD, University of Nebraska:

Colic

Additional relevant MeSH terms:

Colic; Infant, Newborn, Diseases