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

NCT03477669 | Terminated

• 1 other identifier: 0060-18-FB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Colic

Keywords

Colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of Life-The Short Form -36 (SF-36)

  4 weeks

• Calprotectin levels

  4 weeks

Study Arms (2)

chamomile/probiotic arm

EXPERIMENTAL

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

Dietary Supplement: chamomile/probiotic arm

Placebo of chamomile/probiotic arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo of chamomile/probiotic arm

Interventions

chamomile/probiotic arm DIETARY_SUPPLEMENT

Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.

chamomile/probiotic arm

Placebo of chamomile/probiotic arm DIETARY_SUPPLEMENT

Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.

Placebo of chamomile/probiotic arm

Eligibility Criteria

• Age: 3 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Colic

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ruben E Quiros, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 7, 2018
• First Posted: March 26, 2018
• Study Start: May 18, 2018
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)