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

Primary Purpose

Infantile Colic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chamomile/probiotic arm
Placebo of chamomile/probiotic arm
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic focused on measuring Colic

Eligibility Criteria

3 Weeks - 16 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital & Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

chamomile/probiotic arm

Placebo of chamomile/probiotic arm

Arm Description

Infant will receive 5 drops of the study product once per day with a feeding at midday.

Infant will receive 5 drops of a placebo product once a day at midday.

Outcomes

Primary Outcome Measures

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© .

Secondary Outcome Measures

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.
Calprotectin levels
The investigators hope to see a significant decrease in the baby's calprotectin stool levels.

Full Information

First Posted
March 7, 2018
Last Updated
August 23, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03477669
Brief Title
Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
Acronym
Colic
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit study participants
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
Keywords
Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chamomile/probiotic arm
Arm Type
Experimental
Arm Description
Infant will receive 5 drops of the study product once per day with a feeding at midday.
Arm Title
Placebo of chamomile/probiotic arm
Arm Type
Placebo Comparator
Arm Description
Infant will receive 5 drops of a placebo product once a day at midday.
Intervention Type
Dietary Supplement
Intervention Name(s)
chamomile/probiotic arm
Intervention Description
Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo of chamomile/probiotic arm
Intervention Description
Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.
Primary Outcome Measure Information:
Title
Crying time
Description
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© .
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quality of Life-The Short Form -36 (SF-36)
Description
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.
Time Frame
4 weeks
Title
Calprotectin levels
Description
The investigators hope to see a significant decrease in the baby's calprotectin stool levels.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben E Quiros, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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