ColicCRINCT02586558
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
A study testing Experimental Infant formula and Reference group in people with Colic, run by McMaster University at 1 site in Canada.
Trial summary
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. Read more about this study
- Who is it for?
- Ages 2 to 8 weeks
- Conditions the study is for
- Colic
- What is being tested?
- Experimental Infant formula and Reference group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 13 Dec 2017to 15 Aug 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 2 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy, term infant from a singleton birth (=>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
Who cannot join
- Infants with known genetic syndromes; birth weight (<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.
- Conditions
- Colic
- Being tested
- Experimental Infant formula, Reference group
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant formulaOther
Ready-to-feed infant formula to be fed ad libitum
Reference groupOther
Ready-to-feed infant formula to be fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Active comparator | Milk-based infant formula with prebiotics Receives: Other: Experimental Infant formula |
| Reference group | Placebo comparator | Milk-based infant formula without prebiotics Receives: Other: Reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant crying and fussing behaviour
As assessed by the Barr Baby Behavior Diary
Measured: 6 weeks
Secondary outcomes (8)
Infant crying and fussing behaviour
As assessed by actigraphy and accelerometry
Measured: 6 weeks
Stool Microbiota
Measured: 6 weeks
Stool calprotectin
Measured: 6 weeks
Parent satisfaction
As assessed by parent survey
Measured: 6 weeks
Infant behaviour
As assessed by parent survey
Measured: 6 weeks
Infant feeding patterns
As assessed by parent survey
Measured: 6 weeks
Infant stool patterns
As assessed by parent survey
Measured: 6 weeks
Postnatal depression
As assessed by parent survey
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start13 Dec 2017
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Principal investigator, John Cairney, McMaster University
- Investigators
- John Cairney, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586558
- Sponsor's protocol ID
- INCH-681
- Acronym
- CRI
- Status last verified
- Aug 2019
- First submitted
- 23 Oct 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
- ClinicalTrials.gov ID
- NCT02586558
- Acronym / sponsor ID
- CRI / INCH-681
- Conditions
- Colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Active comparator | Other: Experimental Infant formulaMilk-based infant formula with prebiotics |
| Reference group | Placebo comparator | Other: Reference groupMilk-based infant formula without prebiotics |
Who may qualify
- Ages
- 2 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, term infant from a singleton birth (=>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
Key exclusion criteria (1 listed)
- Infants with known genetic syndromes; birth weight (<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
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 |
|---|---|---|
| Experimental Infant formulaReady-to-feed infant formula to be fed ad libitum | Other | Experimental Infant Formula |
| Reference groupReady-to-feed infant formula to be fed ad libitum | Other | Reference group |
Primary outcome
Infant crying and fussing behaviour
Time frame: 6 weeks
As assessed by the Barr Baby Behavior Diary
8 secondary outcomes
Infant crying and fussing behaviour
Time frame: 6 weeks
Stool Microbiota
Time frame: 6 weeks
Stool calprotectin
Time frame: 6 weeks
Parent satisfaction
Time frame: 6 weeks
Infant behaviour
Time frame: 6 weeks
Infant feeding patterns
Time frame: 6 weeks
Infant stool patterns
Time frame: 6 weeks
Postnatal depression
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
John Cairney, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant formula and Reference group in people with Colic, run by McMaster University at 1 site in Canada.
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 1 inclusion and 1 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 28 Aug 2019. 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 Canada. 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: Recruitment issues). 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?
Infant crying and fussing behaviour (time frame: 6 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 28 Aug 2019.