Infantile ColicColicNCT03477669
Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
A study testing chamomile/probiotic arm in people with Infantile Colic, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- chamomile/probiotic arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 25 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
About this study
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
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.
Read the 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.
- Conditions
- Infantile Colic
- Being tested
- chamomile/probiotic arm, Placebo of chamomile/probiotic arm
- Keywords
- Colic
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chamomile/probiotic armDietary supplement
Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
Placebo of chamomile/probiotic armDietary supplement
Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.
| Study group | Role | What they receive |
|---|---|---|
| chamomile/probiotic arm | Experimental | Infant will receive 5 drops of the study product once per day with a feeding at midday. Receives: 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. Receives: Dietary Supplement: Placebo of chamomile/probiotic arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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© .
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
Calprotectin levels
The investigators hope to see a significant decrease in the baby's calprotectin stool levels.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start18 May 2018
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Why it stopped: Unable to recruit study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben E Quiros, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477669
- Sponsor's protocol ID
- 0060-18-FB
- Acronym
- Colic
- Status last verified
- Aug 2023
- First submitted
- 7 Mar 2018
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03477669
- Acronym / sponsor ID
- Colic / 0060-18-FB
- Conditions
- Infantile Colic
- Keywords
- Colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit study participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| chamomile/probiotic arm | Experimental | Dietary Supplement: chamomile/probiotic armInfant will receive 5 drops of the study product once per day with a feeding at midday. |
| Placebo of chamomile/probiotic arm | Placebo comparator | Dietary Supplement: Placebo of chamomile/probiotic armInfant will receive 5 drops of a placebo product once a day at midday. |
Who may qualify
- Ages
- 3 to 16 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chamomile/probiotic armCaregivers will administer 5 drops of the study product once a day with a feeding at mid-day. | Dietary supplement | chamomile/probiotic arm |
| Placebo of chamomile/probiotic armCaregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day. | Dietary supplement | Placebo of chamomile/probiotic arm |
Primary outcome
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© .
2 secondary outcomes
Quality of Life-The Short Form -36 (SF-36)
Time frame: 4 weeks
Calprotectin levels
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Unable to recruit study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben E Quiros, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chamomile/probiotic arm in people with Infantile Colic, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crying time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.