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Management of Infantile Colic

Introduction

Infantile colic has been defined as paroxysmal uncontrollable crying in an otherwise healthy infant less than 3 months of age,with more than three hours of crying per day in more than three days a week and for more than three weeks.1Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.   Colic is a common condition in babies characterised by excessive crying and inability to settle, particularly in the evening and night. Babies can often be seen to draw up their legs towards their stomach as though they are in pain.2Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].   It appears to be unrelated to environmental events.The child cannot be soothed, even by feeding.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Even though this condition is self-limiting and benign, for parents and caregivers this problem is frustrating. The healthcare professionals are frequently consulted with high levels of parental stress and anxiety.1Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.  

Prevalence

In young infants up to 3 months of age, colic is the second-most frequent gastrointestinal (GI) disorder. The incidence peaks around 6 weeks of age and resolves by the age of 3 months.4van de Heijning, Berton A, Bouritius H, et al. GI Symptoms in Infants Are a Potential Target for Fermented Infant Milk Formulae: A Review. Nutrients. 2014;6:3942-3967.  Infant colic affects between 10% and 30% of babies between 3 and 13 weeks, whether breast- or formula-fed.5Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactoseloadwithlactase.JHumNutrDietet.2001;14:359-363.  

One in six families consult a health professional for this condition.6Wade S, Kilgour T. Infantile colic. BMJ. 2000;323:437-440.  The incidence of infantile colic was found to be 3.3-17%, in a two part population-based study (prospective part, 152 mothers and retrospective part, 224 mothers with newborn healthy infants). The incidence depended on the definition used and whether the symptoms were reported prospectively or retrospectively. The classical “Wessel type” colic was present in 9.3%.6Wade S, Kilgour T. Infantile colic. BMJ. 2000;323:437-440.  7Canivet C, Hagander B, Jakobsson I, et al. Infantile colic–less common than previously estimated? Acta Paediatr. 1996;85(4):454-458.   A randomised controlled trial of 97 breast- and formula-fed infants found that, at 2 weeks of age, the incidence of crying more than three hours a day was 43% in formula fed infants and 16% in breast-fed infants.The incidence at 6 weeks in formula-fed and breast-fed infants was 12% and 31%, respectively.6Wade S, Kilgour T. Infantile colic. BMJ. 2000;323:437-440.  8Lucas A, St James-Roberts I. Crying, fussing and colic behaviour in breast- and bottle-fed infants. Early Hum Dev. 1998;53(1):9-18.  

Aetiopathogenesis

It is unclear as to how infantile colic is caused. The evaluation process must consider the underlying organic causes of excessive crying (Table 1). Organic causes account for less than 5% of infants. There are many organic causes of infantile colic with transient lactase deficiency being the most important cause.2Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].  3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

GI disorders: GI disorders have been implicated in colic because of the infant’s leg position and grimacing during a crying spell. Abdominal cramping and colic may be a result of hyperperistalsis. It is supported by evidence that the use of anticholinergic agents decreases colic symptoms. Gut hormones such as motilin also may play a causative role in colic. Motilin is thought to cause hyperperistalsis, leading to abdominal pain and colic.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Psychosocial Disorders: In families with a colicky infant, there may be problems with communication and family functioning, as well as parental anxiety and fatigue.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Neurodevelopmental Disorders: The crying patterns of colicky infants (i.e., peaking around six weeks of age with crying late in the afternoon and evening) are the same in normal infants.However, colicky infants cry longer and are more difficult to soothe once crying has begun. The fact that most infants outgrow colic by four months of age, lends support to a neurodevelopmental cause of colic.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Transient Lactase Deficiency: Studies have shown transient lactase deficiency to be an important cause of colic in some babies.It is believed that this is a result of babies being born with an immature digestive system, so that they do not produce sufficient quantitiesof the lactase enzyme todigest the lactose intheir food.2Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].  

The resulting failure to break down all the lactose in the feed allows significant amounts of lactose in breast milk or formula to enter the large bowel. It then becomes a substrate for lactobacilli and bifidobacteria in the colon, which break it down in a fermentation reaction to produce lactic acid and hydrogen.

The subsequent increase in breath hydrogen is an accepted indirect biomarker for hypolactasia and has been reported in infants with colic. The rapid production of hydrogen in the lower bowel distends the colon, causing pain. The osmotic pressures generated by the lactose and lactic acid in the colon cause an influx of water, leading to further distension and acidic diarrhoea.9Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactose load with lactase. Available from: http://coliefthcy.com/Trial2/ [Accessed on 25 September 2016].  

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As the babymatures, the levels of lactase enzyme naturally produced may increase so that by the time the baby is 3-4 months old, it often growsoutof itslactoseintolerancesymptoms(anditscolic).2Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].  

Some common theories as to what causes infantile colic are shown below (Figure 1).2Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].  

The absence of atopic manifestations in majority of infants with colic suggests that non-IgE-mediated mechanisms predominate in the pathogenesis of infantile colic.11Heine RG, Hill DJ. Infantile Colic and Food Allergy. Metcalfe DD, Sampson HA (eds.).Food Allergy: Adverse Reaction to Foods and Food Additives. 5th edition. Sussex,United Kingdom. 2014.  

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Diagnosis

When parents seek advice about a colicky baby, their concerns must be substantiated by the physician. There may indeed be an underlying organic cause in an infant presenting with excessive crying.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Detailed History Taking: The physician should ask about the infant’s behaviour and the time of day and length of the crying episodes. Parents should be asked to document this information.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  Figure 2 shows the points to be noted down in a ‘colic diary’.10Colic Recognition Insight Education & Support (CRIES). Available from:th http://colic.org/ [Accessed on 25 September 2016].  

A history of apnoea, cyanosis, or struggling to breathemay suggest previously undiagnosed pulmonary or cardiac conditions.Documentationof frequency andquantityof spittingupis necessary toruleoutgastroesophageal refluxorpyloric stenosis.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

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Physical Examination: It begins with careful observation while the infant is being held on the parent’s lap. The infant is observed for lethargy, poor skin perfusion, and tachypnoea. A rectal temperature greater than 38℃ (100.4℉) or poor weight gain suggests infection, a GI disorder, or nervous system disorder, and requires further work-up. During the examination, the infant’s clothing should be removed to facilitate inspection of the skin for evidence of trauma and palpation of the large bones for possible fractures, which may indicate abuse. The examination may proceed with the infant in the parent’s lap or on the examination table. A thorough GI and neurologic examination should be performed. The examination itself may reassure the parents.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Laboratory Tests and Radiographic Examination: These are unnecessary if the child is gaining weight normally and has a normal physical examination.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.  

Assessment

A baby crying excessively, drawing the knees up to the stomach,or arching the back should be reviewed for the presence of infant colic by assessing and documenting the following conditions :12The Joanna Briggs Institute, Royal Adelaide Hospital. The effectiveness of interventions for infant colic. Best Practice. 2008;12(6):1-4.  

  • General health of the baby
  • Antenatal and perinatal history
  • Onset and length of crying
  • Nature of the stools
  • Feeding assessment
  • Woman’s diet, if breastfeeding
  • Family history of allergy
  • Parent’s response to the baby’s crying

Rome IV Diagnostic Criteria for Infant Colic

The new Rome IV criteria, which classify infant colic as a functional gastrointestinal disorder (FGID) in infants from birth to 5 months of age, require all of the following 13Rome Foundation. Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. Available from: http://www.romecriteria.org/assets/pdf/19_RomeIII_th apA_885-898.pdf [Accessed on 25 September 2016].  :

  • Age
  • Recurrent and prolonged periods of crying, fussing, or irritability that start and stop without obvious cause and cannot be prevented or resolved by caregivers.
  • No evidence of failure to thrive, fever or illness
  • Caregiver reports crying/fussing for ≥3 hours per day ≥3 on days/week in a telephone or face-to-face interview
  • Total daily crying is confirmed to be ≥3 hours when measured by at least one prospectively kept 24-hour diary

Management

The mainstay of colic management is an acknowledgment by the physician of the difficulties the parents are facing and an inquiry into the well-being of the parents.3Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.   WHO recommends exclusive breast feeding in infancy.

Diet Modification: Based on the theory that infantile colic results from excessive gas production from poor gut digestion of cow’s milk proteins, several nutritional interventions are suggested:1Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.  

Lactase Therapy: In lactase therapy, lactase drops are mixed with breast or bottle milk feeds up to 24 hours prior to feeding the infant.1Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.  

Source of Lactase

Lactase is considered as Generally Recognised As Safe (GRAS).Source of lactase impacts the pH stability of final preparation which decides the dosage, efficacy, safety and cost.

Regulatory bodies like Food Safety and Standards Authority of India (FSSAI)14Food Safety and standards Authority of India. Available from:http://old.fssai.gov.in/Portals/0/pdf/minutes_of_14th_authority_meeting(02.09.14).pdf [Accessed on 19th Feb 2017].   (India) European Food Safety Authority (EFSA)15EFSA panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on Lactose thresholds in lactose intolerance and galactosaemia. EFSA Journal. 2010;8(9):1777. Available from: www.efsa.europa.eu/efsajournal.htm   and U.S. Food and Drug Administration (USFDA)16U.S. Food and Drug Administration. Enzyme Preparations used in food (Partial list).Available from : http://www.fda.gov/Food/Ingredients PackagingLabeling/GRAS/EnzymePreparations/default.htm.  , approve and recommend Aspergillus oryzaeas a source for lactase.

Lactase from Aspergillus oryzae has high activity throughout the GI tract, even in stomach where pH is less than 3.5, unlike other formulations which are unstable at less pH of 3.5 (thus acts independent of pH).17SPark YK, De Santi MSS and Pastore GM. Production and characterization of betagaactosidase from aspergillus oryzae. J Food Sci.1979;44:100-103.  

Benefits of Lactase fromAspergillusoryzaeSource vs.Others Lactase from Aspergillus oryzae has been approved by FSSAI (India). Lactasepreparations fromAspergillusoryzae are stable in an acidic environment andarepracticallypHindependent. This lactase has high activity throughout the GI tract, even in lower stomach where pH is less than 3.5 (Independent of pH). Unlike other formulations which are unstable at less than pH of 3.5. Guidelines such as EFSA, USFDA recommends this source. Lactase from. Aspergillusoryzaesource is consideredGRAS by EFSA.14Food Safety and standards Authority of India. Available from:http://old.fssai.gov.in/Portals/0/pdf/minutes_of_14th_authority_meeting(02.09.14).pdf [Accessed on 19th Feb 2017].   15EFSA panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on Lactose thresholds in lactose intolerance and galactosaemia. EFSA Journal. 2010;8(9):1777. Available from: www.efsa.europa.eu/efsajournal.htm   16U.S. Food and Drug Administration. Enzyme Preparations used in food (Partial list).Available from : http://www.fda.gov/Food/Ingredients PackagingLabeling/GRAS/EnzymePreparations/default.htm.    17SPark YK, De Santi MSS and Pastore GM. Production and characterization of betagaactosidase from aspergillus oryzae. J Food Sci.1979;44:100-103.  

Benefits of Lactase in Infant Colic

  • Recommended as per international guidelines and textbooks [National Institute for Health and Care Excellence (NICE)guidelines, American Academy of Pediatrics Committee of Nutrition, Nelson Pediatrics] for providing sufficient lactase to infant to digest milk.
  • GRAS safe (natural enzyme food supplement).
  • Relieves symptoms of infantile colic like excessive crying (by 45%) as well as symptoms of abdominal pain, bloating,vomiting, loose and watery stools.
  • Improves parent and child bonding, parental care and reduces risk of child abuse.
  • In rotaviral and other GI infections, reduces diarrhoea and colicky symptoms (due to transient lactose intolerance),enabling improved nutritional intake.
  • Easy to use, great tasting natural supplement that promotes mother’s milk (and can also be used with formula feeds).

Pharmacological Management: Systematic approach to the management of infantile colic is described in Table 2.18Kanabar D. Current treatment options in the management of infantile colic.Prescriber. 2008;19(7):24-8.  

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Behaviour Modification: There are several behavioural interventions that aim to provide reassurance to parents and offer alternative methods to treat colic. One systematic review classified two trials where modified parent and infant interaction led to significant reduction in colic symptoms. The identification of effective coping strategies and consoling methods to assist parents in managing this stressful condition is imperative.1Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.  

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Prevention

Various clinical trials have also showed that there is 45% reduction in total crying time in infants by use of lactase enzyme.5Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactoseloadwithlactase.JHumNutrDietet.2001;14:359-363.   The NICE clinical knowledge summary for infantile colic suggests a oneweek trial of lactase as an option for infants of parents who are unable to cope despite advice and reassurance for infantile colicky pain.19Data on file.  

Few clinical trials have reported effectiveness of lactase in reducing symptoms of lactose intolerance in paediatric population. Two studies were conducted on infants are described below.

Kearney et al., conducted a randomised, double-blind, crossover trial (13 babies) to investigate lactase in the management of infant colic. According to the study, colic symptoms began in less than 1 month in 12 of the babies. The effect of the lactase was to reduce crying time by 1.14 h per day (2.57 h with placebo & 1.43 h with lactase drops). The reduction in crying time was significant (t = 2.75, d.f. = 11, p = 0.01).20Kearney PJ, Malone AJ, Hayes T, et al. A trial of lactase in the management of infant colic. J Hum Nutr Dietet. 1998;11:281-285.  

A double-blind randomised placebo-controlled crossover study was conducted by Kanabar D et al., (53 babies) to investigate improvement of symptoms in infant colic following reduction of lactose load with lactase. The study reported that pre-incubation feed with lactase resulted in lower hydrogen levels and total crying time 45% lower than figures with placebo treatment (Figure 3).5Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactoseloadwithlactase.JHumNutrDietet.2001;14:359-363.  

Conclusion

Infants and premature babies lack lactase enzyme in their GI tract.Lactase replacement treats the original root cause of Infant Colic due to lactose intolerance. If colic symptoms improve with lactase, then it should continue for a 4-month period. Lactase can also be considered as a diagnostic agent in infant colic (if lactase decreases crying time, the same can be continued for 4 to 6 months and tapered thereafter). Studies have shown reduction in crying time, symptoms and reduction of expired H in lactose 2 hydrogen breath test (reduction offered till 45%). Lactase enzyme promotes breastfeeding, as it aides in digestion of lactose and decreases the incidence of infant colic.

References

  1. Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102.
  2. Lacteeze. Treating Colic Naturally: What is Colic? Available from: http://www.th lacteeze.com.au/colic.html [Accessed on 25 September 2016].
  3. Roberts DM, Ostapchuk M, O’Brien JG. Infantile Colic. Am Fam Physician. 2004;70:735-740.
  4. van de Heijning, Berton A, Bouritius H, et al. GI Symptoms in Infants Are a Potential Target for Fermented Infant Milk Formulae: A Review. Nutrients. 2014;6:3942-3967.
  5. Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactoseloadwithlactase.JHumNutrDietet.2001;14:359-363.
  6. Wade S, Kilgour T. Infantile colic. BMJ. 2000;323:437-440.
  7. Canivet C, Hagander B, Jakobsson I, et al. Infantile colic–less common than previously estimated? Acta Paediatr. 1996;85(4):454-458.
  8. Lucas A, St James-Roberts I. Crying, fussing and colic behaviour in breast- and bottle-fed infants. Early Hum Dev. 1998;53(1):9-18.
  9. Kanabar D, Randhawa M, Clayton P. Improvement of Symptoms in infant colic following the reduction of lactose load with lactase. Available from: http://coliefthcy.com/Trial2/ [Accessed on 25 September 2016].
  10. Colic Recognition Insight Education & Support (CRIES). Available from:th http://colic.org/ [Accessed on 25 September 2016].
  11. Heine RG, Hill DJ. Infantile Colic and Food Allergy. Metcalfe DD, Sampson HA (eds.).Food Allergy: Adverse Reaction to Foods and Food Additives. 5th edition. Sussex,United Kingdom. 2014.
  12. The Joanna Briggs Institute, Royal Adelaide Hospital. The effectiveness of interventions for infant colic. Best Practice. 2008;12(6):1-4.
  13. Rome Foundation. Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. Available from: http://www.romecriteria.org/assets/pdf/19_RomeIII_th apA_885-898.pdf [Accessed on 25 September 2016].
  14. Food Safety and standards Authority of India. Available from:http://old.fssai.gov.in/Portals/0/pdf/minutes_of_14th_authority_meeting(02.09.14).pdf [Accessed on 19th Feb 2017].
  15. EFSA panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on Lactose thresholds in lactose intolerance and galactosaemia. EFSA Journal. 2010;8(9):1777. Available from: www.efsa.europa.eu/efsajournal.htm
  16. U.S. Food and Drug Administration. Enzyme Preparations used in food (Partial list).Available from : http://www.fda.gov/Food/Ingredients PackagingLabeling/GRAS/EnzymePreparations/default.htm.
  17. Park YK, De Santi MSS and Pastore GM. Production and characterization of betagaactosidase from aspergillus oryzae. J Food Sci.1979;44:100-103.
  18. Kanabar D. Current treatment options in the management of infantile colic.Prescriber. 2008;19(7):24-8.
  19. Data on file.
  20. Kearney PJ, Malone AJ, Hayes T, et al. A trial of lactase in the management of infant colic. J Hum Nutr Dietet. 1998;11:281-285.
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