A study of the effects of Colief in infants with persistent abdominal colic
| ISRCTN | ISRCTN10305018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10305018 |
| Secondary identifying numbers | CCL-001 |
- Submission date
- 09/03/2017
- Registration date
- 22/03/2017
- Last edited
- 21/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
MMI Ltd
Devonshire House
Manor Way
Borehamwood
WD6 1QQ
United Kingdom
Study information
| Study design | Multinational multicentre randomized placebo-controlled double-blind crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Multinational, multicentre, randomized, placebo-controlled, double-blind, crossover study of lactase in infant subjects with symptoms of abdominal colic |
| Study acronym | COLIIC |
| Study objectives | Colief will prove significantly better than placebo in reducing crying time in infants with infantile colic with classically-defined infantile colic. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2016 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 21 Days |
| Upper age limit | 90 Days |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Australia
- England
- Hong Kong
- United Kingdom
- United States of America
Study participating centres
Australia
Hong Kong
Hong Kong
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United States of America
United States of America
United States of America
United States of America
Sponsor information
Industry
The Herbert Building
The Park, Carrickmines
Dublin
Dublin 18
Ireland
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
