An interventional study of chamomile/probiotic arm and Placebo of chamomile/probiotic arm in Infantile Colic, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 3 Weeks to 16 Weeks. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
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.
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 1 is below the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infant will receive 5 drops of the study product once per day with a feeding at midday.
Dietary Supplement: chamomile/probiotic arm
Infant will receive 5 drops of a placebo product once a day at midday.
Dietary Supplement: Placebo of chamomile/probiotic arm
Drug pages: Chamomile extract · Matricaria chamomilla · Apigenin · Probiotic
Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.
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© .
Time frame: 4 weeks
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.
Time frame: 4 weeks
Calprotectin levels
The investigators hope to see a significant decrease in the baby's calprotectin stool levels.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Feb 2019, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Chamomile extract · Matricaria chamomilla · Apigenin · Probiotic