Condition category
Signs and Symptoms
Date applied
09/03/2017
Date assigned
22/03/2017
Last edited
21/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Michael Bowles

ORCID ID

Contact details

MMI Ltd
Devonshire House
Manor Way
Borehamwood
WD6 1QQ
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Crosscare Ltd

Sponsor details

The Herbert Building
The Park
Carrickmines
Dublin
Dublin 18
Ireland

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes