Plain English Summary
Background and study aims
Colic is excessive, frequent crying in a baby who appears to be otherwise healthy. It is known that 38% or more cases of infant colic are related to a temporary lack of the lactase enzyme, causing lactose (a sugar found in milk) to build up in the gut and then ferment. By providing lactase in the milk feed, the lactose will be digested. The aim of this study is to assess the effect of lactase (as the marketed product Colief) in the treatment of young babies who have colic.
Who can participate?
Babies between the ages of 21 and 90 days with abdominal colic
What does the study involve?
Participating babies are randomly allocated to have either lactase or a placebo (dummy drug) added to their formula milk feeds over two 10-day periods with a 4-day break in between. Improvement in colic symptoms is assessed by measuring crying time using a diary completed by the parent or guardian during the two treatment periods. Other than physical examination of the babies the study does not involve intervention of any kind (e.g. blood samples or X-rays).
What are the possible benefits and risks of participating?
Babies may benefit from relief of their abdominal colic if the symptoms are due to lactase deficiency. Parents/guardians may therefore benefit from reducing their anxiety levels and improving their sleep patterns. If the symptoms are reduced, the product (Colief®) is available for purchase. There are no other lactase products for infants demonstrated as effective and so without alternatives the infant would probably continue to have symptoms until lactase is produced naturally. The tested product is a nutritional supplement (natural biological product) added to the formula feeds in low doses and as such the foreseeable risks are negligible. The product has also been available on the market in many countries for many years.
Where is the study run from?
1. Springvale Medical Centre (UK)
2. Sandwell General Hospital (UK)
3. St Mary’s Hospital (UK)
4. Miami Children’s Hospital (USA)
5. New York Children’s Hospital (USA)
6. Duke Children’s Hospital (USA)
7. Chicago Lurie Children’s Hospital (USA)
8. Kwong Wah Hospital (Hong Kong)
9. Prince of Wales Hospital (Hong Kong)
10. The Royal Children’s Hospital Melbourne (Australia)
When is the study starting and how long is it expected to run for?
September 2016 to December 2017
Who is funding the study?
Crosscare Ltd (Ireland)
Who is the main contact?
Dr Michael Bowles
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCL-001
Study information
Scientific title
Multinational, multicentre, randomized, placebo-controlled, double-blind, crossover study of lactase in infant subjects with symptoms of abdominal colic
Acronym
COLIIC
Study hypothesis
Colief will prove significantly better than placebo in reducing crying time in infants with infantile colic
with classically-defined infantile colic.
Ethics approval
1. Integrated Research Application System (IRAS) (UK) - pending
2. Kowloon Central Cluster Ethics Committee (Hong Kong) - pending
3. University of Melbourne Ethics Committee (Australia) - pending
4. Institutional Review Board (IRB) Children's Hospital Miami, Florida (USA) - pending
Study design
Multinational multicentre randomized placebo-controlled double-blind crossover study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Infantile abdominal colic
Intervention
Participants will be randomized to receive the following treatments over two 10-day periods with a 4-day washout period between treatments:
1. Lactase (Colief) treated milk feeds (4 drops of solution added to each formula feed)
2. Placebo (4 drops of matching placebo added to each formula feed)
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Crying time, measured in minutes from diary cards completed by parents/guardians over each 10-day treatment period
Secondary outcome measures
1. Fussing/fretting time
2. Stool frequency
3. Overall parent evaluation
Measured from the diary cards completed by parents/guardians during each 10-day treatment period
Overall trial start date
01/09/2016
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female babies between the ages of 21 and 90 days inclusive at time of study entry
2. Born at a gestational age of at least 32 weeks and with a birth weight of at least 2000 g
3. Symptoms of abdominal colic for at least 3 hours per day for at least 3 days per week present over the preceding 2 weeks
4. Associated signs of spasm and/or lower limb flexure and/or diarrhoea
5. Otherwise healthy babies
6. Parents/guardians willing to consent to their baby participating in the study
7. Exclusively bottle-fed babies
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Age <21 days or >90 days at date of study entry
2. Born at <32 weeks gestation or with birth weight <2000 g
3. Any significant congenital disorder
4. Any significant co-existing disease
5. Partially breast-fed
6. Receiving any other anti-colic medicines
7. Known intolerance to beta-galactosidase (lactase)
Recruitment start date
01/04/2017
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Australia, Hong Kong, United Kingdom, United States of America
Trial participating centre
Melbourne Children's Hospital
Victoria 3052
Australia
Trial participating centre
Kwong Wah Hospital
-
Hong Kong
Trial participating centre
Prince of Wales Hospital
-
Hong Kong
Trial participating centre
Burncross Surgery
S35 1RN
United Kingdom
Trial participating centre
Sandwell General Hospital
B71 4HJ
United Kingdom
Trial participating centre
Springvale Medical Centre
YO21 1SD
United Kingdom
Trial participating centre
St Mary’s Hospital, London
W2 1NY
United Kingdom
Trial participating centre
Miami Children's Hospital
FL 33155
United States of America
Trial participating centre
New York Children's Hospital
NY 10032
United States of America
Trial participating centre
Duke Children’s Hospital
NC 27710
United States of America
Trial participating centre
Chicago Lurie Children’s Hospital
IL 60611
United States of America
Funders
Funder type
Industry
Funder name
Crosscare Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The plan is to publish as one main paper in a peer reviewed journal during the last quarter of 2018.
IPD sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
01/10/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list