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New Research : Summary of Improvement of Symptoms
of Infant Colic following
Reduction of Lactose Load with Lactase


D Kanabar, M Randhawa, P Clayton

Dept Paediatrics, Guy’s Hospital, London and Cross Care Ltd., Dublin.

Full report : October issue of the Journal of Human Nutrition & Dietetics 2001 (14, 359-363)

In a recent trial at Guy’s Hospital London, which shows an improvement symptoms of infant colic following reduction of lactose load with lactase.  These results are particularly significant as there have been very few studies on colic over the past 10 years although it affects around 30% of newborns.  In addition, the results offer a way for breastfeeding mothers to continue breastfeeding, by adding lactase drops to their pre-feed. Just express two teaspoons of breast milk into a sterilised container, add 4 drops of lactase drops, feed back to the baby using a sterilised plastic spoon and start breast-feeding immediately. 

Professor Kanabar et al.’s study was conducted using the enzyme from Crosscare – the same formula as used in Colief Infant Drops - the active ingredient is the naturally occurring enzyme lactase.  Milk, dairy products, infant formulas and breast milk all contain a complex sugar called lactose. Lactase is the enzyme our bodies normally produce to break down the lactose into the simpler sugars glucose and galactose, so that it can be easily absorbed. Undigested lactose in foods can cause temporary digestive discomfort, bloatedness and wind. This is sometimes called transient lactose intolerance, which can be an important factor in babies with colic. Trials at Guy's Hospital have confirmed that approximately 40% of infant colic cases responded positively to being fed milk treated with lactase. Colief is a natural approach to infant colic; it is a food supplement, not a drug or a medicine. It can be used safely from birth onwards and is suitable for babies who are breast or bottle fed. 


 1) Transient lactose intolerance has been identified as a possible causative factor in
infant colic.


2)Infant Colic affects between 10% and 30% of babies between 3 and 13 weeks
(James-Roberts 1991, Weisbult 1994) whether breast or formula fed (Adams
1987, Thomas et al 1987).

3)Colic may contribute to impaired parent-child bonding, and increase the risk of
child abuse (Sumpter 1987).


4)One current theory suggests that colic may be caused by transient relative lactase
deficiency, which may reflect an immature digestive system (Levitt 1969, Barr
et al 1989, Miller at al 1990).

5)The subsequent increase in breath hydrogen is an accepted indirect biomarker for
hypolactasia (Levitt 1969), and has been reported in infants with colic (Moore et
al 1988, Miller et al 1989, Barr 1990).

6)This model of colic implies that symptoms could be relieved by reducing the
lactose content of the infant’s feed.

7)This hypothesis has already been tested in a small double-blind study in which
the feed of colicky babies was pre-incubated with lactase (Kearney et al 1998).
The results were positive, but the trial size (N=13) precluded formal proof.

8) The trial at Guy’s Hospital was double-blind and placebo-controlled, with randomised entry and cross-over, and n=53.

9) Parental consent was obtained after full explanation of the purpose and
nature of the trial, and the trial was approved by the Guy’s and St Thomas’
Ethics Committee

10) Infants who met the trial criteria (at last 3 hours full-force crying per day for at least 3 days per week for at least two weeks) were assessed in the active and the placebo phases of the study for colic symptoms and breath hydrogen.


11) Pre-incubation of the feed with lactase resulted in breath hydrogen levels
and total crying time, which were both at least 45% lower than figures with
placebo treatment in 35% of compliers.

12) The findings suggest that infant colic may have a multiple aetiology, and
that in a significant number of cases the immediate cause is transient lactose
intolerance, in which cases pre-treatment of feeds with lactase can result in ; considerable symptomatic benefits.

Our study was designed to screen the efficacy of lactose load reduction in infant
colic at the primary healthcare level.  The trial findings are unlikely to apply to   infants referred to Paediatric Gastroenterology Units, where alternative aetiologies  may predominate.

Tania Rivera
Account Manager
Pegasus Public Relations

Tel : 01903 821550
Fax : 01903 821552