Trials / Terminated
TerminatedNCT02586558
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- McMaster University · Academic / Other
- Sex
- All
- Age
- 2 Weeks – 8 Weeks
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Experimental Infant formula | Ready-to-feed infant formula to be fed ad libitum |
| OTHER | Reference group | Ready-to-feed infant formula to be fed ad libitum |
Timeline
- Start date
- 2017-12-13
- Primary completion
- 2019-08-15
- Completion
- 2019-08-15
- First posted
- 2015-10-26
- Last updated
- 2019-08-28
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02586558. Inclusion in this directory is not an endorsement.