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

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.

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