Understanding Infant Colic Drops

Welcoming a newborn into the family is an exhilarating and joyous experience, but it often comes with challenges.

Among these is the distressing condition known as infant colic, characterized by prolonged periods of intense crying in an otherwise healthy baby. Alongside colic, some infants may suffer from gastroesophageal reflux (GER), leading many parents to explore the use of colic drops and antacids.

This blog aims to provide a comprehensive understanding of these remedies, their usage, effectiveness, and safety considerations.

"It is also interesting to note that the research has found that colic is reported equally for both breastfed and bottle-fed infant and is not gender specific"...

What is Infant Colic?

Infant colic is a common condition affecting about 4% to 28% of infants (The Cochrane Collaboration, 2016). It typically begins within the first few weeks of life and peaks around 6 weeks, often resolving by 3 to 4 months of age. Research in this field has been conducted over 50 years, and the pathogenesis is still not fully understood. The exact cause of colic is unknown, but it is characterized by:

Intense, inconsolable crying for at least 3 hours a day, 3 days a week, for 3 weeks or more.
Crying episodes often occur in the late afternoon or evening
There may be clenching of the fists, arching the back, or pulling the legs towards their abdomen.

Some older studies defined infantile colic as: “post-prandial attacks of screaming and crying, unabated by maternal comforting, vomiting and sleep disturbance”, “the diagnosis was based on rhythmical attacks of screaming in the evenings in well, thriving babies who were gaining not less than seven oz per week during the period of observation, screaming unabated when the baby was picked up”(The Cochrane Collaboration, 2016).

It is also interesting to note that the research has found that colic is reported equally for both breastfed and bottle-fed infant and is not gender specific (F1000Research 2018).

What are Infant Colic Drops?

Infant colic drops are over-the-counter remedies designed to alleviate the symptoms of colic. It is important to note that there still is no clear evidence-based approach to manage persistent infant crying. The products marketed for infant colic is therefore not formulated according to scientific findings or guidelines. They come in various formulations, including:

Simethicone Drops: These are anti-foaming agents that act as a detergent to help reduce gas bubbles in the stomach and intestines, claiming to make it easier for the baby to pass gas and feel more comfortable. Simethicone is considered safe and is not absorbed into the bloodstream.
Herbal Remedies: Some colic drops contain herbal ingredients like fennel, chamomile, or ginger, which are believed to have soothing properties. These drops are often marketed as natural solutions for colic relief; however we have limited safety and efficacy studies. These products are also rarely regulated by the FDA.
Probiotics: Certain probiotic formulations claim to improve gut health and reduce colic symptoms by balancing the gut microbiota. Lactobacillus reuteri is a commonly studied probiotic in this context.
Lactase enzyme: Some older studies suggest that the slow digestion of lactose, the main carbohydrate in breast/formula milk, can cause fermentation and build up of gas. Breast milk is known to contain lactase, the enzyme which is responsible for the break down of lactose to make it available for absorption. In some cases, mothers are thought to have higher amounts of lactose in their milk, while infants are not yet able to produce their own lactase enzyme to aid in the increased need for digestion. Similarly standard infant formula also contains mainly lactose as the carbohydrate; however it does not contain any lactase enzymes. There are specialty formulas which reduce the lactose content and substitute with alternatives in attempt to reduce gastrointestinal discomfort.

What are Antacids for Infants?

Antacids are medications that neutralize stomach acid, and they are sometimes used in infants to treat symptoms of gastroesophageal reflux (GER). GER occurs when stomach contents flow back into the esophagus, causing discomfort and, in some cases, regurgitation or vomiting. Common antacids and related medications used in infants include:

Histamine-2 (H2) Blockers: Medications like ranitidine (no longer widely used due to safety concerns) and famotidine reduce the production of stomach acid.
Proton Pump Inhibitors (PPIs): Drugs such as omeprazole and lansoprazole block the enzyme responsible for acid production, providing longer-lasting relief.
Antacid Suspensions: Over-the-counter liquid antacids may be given to neutralize stomach acid, but these are typically not recommended for prolonged use in infants.

Safety and Effectiveness

Colic Drops

Simethicone Drops: Generally considered safe with few side effects. However, studies on their effectiveness are mixed, with some showing minimal benefit.
Herbal Remedies: While some parents report success with herbal colic drops, the evidence is largely anecdotal. It’s important to choose products that are specifically formulated for infants to avoid potential adverse effects.
Probiotics: Emerging research suggests that certain probiotics may help reduce colic symptoms, but more studies are needed to confirm their effectiveness and optimal strains. Infants suffering from colic are thought to have gut microbiome dysbiosis (low beneficial bacterial count and/or diversity). More specifically the infants examined in the research were found to have low levels of bifidobacteria and lactobacilli, which support anti-inflammatory properties. The probiotic strain Lactobacillus reuteri DSM 17938 is the most extensively studied probiotic for colic, especially in breastfed infants (F1000Research 2018).
Lactase enzyme: There may be some promise in trying to reduce these undigested carbohydrates in the infant’s gut through oral lactase administration. There is some evidence that oral lactase can reduce crying time. The United Kingdom National Institute for Health and Care Excellence (NICE) guidelines recommend a trial of 2 weeks’ administration of lactase (F1000Research 2018). These recommendations are based on very few studies, and more clinical evidence is required.

Antacids

The evidence on the use of antacids in infants is limited, with minimal reports of efficacy. The infant gut is known to be much less acidic than that of an adult, with an average estimated pH of 4 to 6 for infants and 2 for adults. This is attributed to the frequent consumption of milk feeds with less anticipatory acid production.

H2 Blockers and PPIs: These medications might aid in reducing acid-related symptoms, but they should only be used under medical supervision. Long-term use can affect nutrient absorption and gut health.
Antacid Suspensions: Short-term use may provide relief, but prolonged use is not recommended due to potential side effects like constipation, altered calcium metabolism and altered nutrient absorption.

Considerations for Parents

It is important for use to consider the fact that parental reporting of infantile colic or related symptoms can be influenced by many factors such as depression, anxiety, sleep deprivation and lack of knowledge on normal infant behavior.

A lot of the clinical trials done on this topic rely on parental reporting of symptoms, which is naturally subject to bias. We have evidence to show that there is significant overreporting of infant crying times and fussing by parents. All of these aspects add to the difficulty and complexity of researching and managing infantile colic. If the infant’s symptoms are creating significant parental distress or depression, it may impact the parent-child relationship.

In this case, parents may feel a sense of satisfaction or relief if they are able to administer some form of treatment. With limited evidence and recommendations on the use of these products, it is the responsibility of the health care professionals to assess each individual parent and infant dyad, educate on the possible treatment attempts and assist in outweighing the pros and cons of these treatments.

To quote the recommendations from the review done by Siel Daelemans et al in 2018; “Infantile colic is not a reason to stop breastfeeding. Lactobacillus reuteri DSM 17938 supplementation could reduce parental discomfort due to infantile colic. For bottle-fed infants, the first-line approach recommended in infants who are not suspected of suffering from cow’s milk protein allergy are formulae with partially hydrolysed whey proteins, with reduced lactose with prebiotic oligosaccharides and probiotics. Above all, parental support remains imperative.”

That being said, consider following the steps below if you feel that your baby is suffering from colic-like symptoms:

Consult a Healthcare Professional: Always discuss with your pediatrician before starting any medication or supplement for your baby. They can help determine the cause of your baby’s distress and recommend appropriate treatments.
Monitor for Side Effects: Keep an eye on any adverse reactions your baby might have to colic drops or antacids, and report these to your healthcare provider.
Non-Medical Interventions: Sometimes, simple measures like changing feeding techniques, ensuring proper burping, and soothing strategies (e.g., massaging, bathing, swaddling, gentle rocking) can significantly help alleviate colic symptoms. Maternal diet is often blamed for the infant’s discomfort, however the evidence for maternal dietary manipulation is weak (F1000Research 2018). Discuss this option with your dietitian before going on an extensive elimination diet.
Holistic Approach: Consider a combination of interventions, such as environmental modifications and elimination of external stressors to create a calm and comfortable setting for your baby.

Conclusion

Infant colic and gastroesophageal reflux can be challenging for both babies and parents, but understanding the available remedies and their suggested use can make a significant difference.

Parents often fall into a spiral of product use, adding one on top of the other. This prevents proper assessment of symptom relief or treatment effectivity, while adding to the risk of side effects. Remember that these products should not be used chronically, but rather for shorter periods while monitoring symptoms and allowing for periods of rest. Always prioritize safety and consult with healthcare professionals to ensure the best care for your little one.

A plea to my fellow healthcare professionals, let us do our best to understand these treatments, research them and educate our clients on the use.

If you have any questions related to this topic, please contact me.

Product Name	Category and claims	Ingredients	Evidence on safety and efficacy as per clinical reviews for ingredient in Bold
Telament Colic drops	Anti-foaming agent used to reduce bloating, discomfort or pain caused by excessive gas	Simethicone, Preservatives: Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, Benzyl Alcohol 0.5%	Limited studies (3) Very low to Low quality evidence Biased results (The Cochrane Collaboration, 2016) Several randomised placebo-controlled trials Simethicone was found to be ineffective (Bailey et al. 2013)
Gripe Water	Herbal remedy for colic and other gastrointestinal ailments and discomforts of infants	Each 5 ml liquid contains: Sodium bicarbonate - 50,00 mg. Dill seed oil, terpeneless - 2,15 mg. Preservative: Nipasept sodium - 0,1 %m/v. Contains sugar: Sucrose - 1g. Alcohol content - 4.4 %	Limited studies (1) Very low to Low quality evidence Biased results (The Cochrane Collaboration, 2016) The possible perceived effectiveness is because of the alcohol content, which may induce sleep and relaxation in the infant (Bland et al. 2014)
Colix	The enzyme Lactase breaks down the milk sugar (lactose) into the two sugars, glucose and galactose, which are readily absorbed into the bloodstream to try and prevent the buildup of gas in the colon	Lactase Enzyme Preservative free	Lactase is an effective form of treatment only in those cases where colic is a result of transient lactose intolerance. (Savino et al. 2014b) There is some evidence that oral lactase can reduce crying time. The United Kingdom National Institute for Health and Care Excellence (NICE) guidelines recommend a trial of 2 weeks’ administration of lactase (F1000Research 2018).
Colief Infant Drops	The lactase enzymes which helps to break down lactose in your baby's milk	Glycerol, Water and Lactase Enzyme
CalmCo Probiotic Drops	Probiotic – multi-strain	P.pentosaceus KABP™ -041 (1B CFU) B.longum KABP-042 L.plantarum KABP-051 (0.5B CFU) L.brevis KABP-052 P.acidilactici KABP-053 400 IU Vitamin D Other Ingredients: Sunflower Oil, Silicon Dioxide, Natural Vitamin E (as Tocobiol™, a natural sunflower source)	Emerging evidence on the use of probiotics for management of infant colic. A few studies have found that certain probiotic combinations were more effective in reducing colic symptoms than simethicone. (Health SA Gesondheid, 2019) Lactobacillus. reuteri DSM 17938 was shown in a preventive trial to decrease all FGIDs, including colic. In all trials, probiotic supplementation was not associated with any adverse events. F1000Research 2018)
Reuterina	Probiotic – single-strain patented lactic acid bacterium	100 million live, freeze-dried colony forming units (CFU) Limosilactobacillus reuteri Protectis® (strain DSM 17938). Excipients: Medium chain triglyceride oil, silicon dioxide, sunflower oil
Colief Probiotic	Probiotic – single-strain lactic acid bacterium	1.1 billion live cultures of Lactobacillus rhamnosus, LGG®, Bifidobacterium infantis. Other ingredients: Sunflower oil. Preservative: dl-alpha-tocopherol
Muthi Wenyoni	Antacid - traditional mixture for indigestion and reflux	Calcium Carbonate, Magnesium Carbonate, Sodium Bicarbonate, Sodium Citrate, Preservatives: Methylparaben, Propylparaben, Sugar: Sucrose, Tartrazine	No clinical studies have been conducted on the efficacy of calcium carbonate and magnesium carbonate for infant colic. The possible perceived effectiveness is because of the alcohol content, which may induce sleep and relaxation in the infant (Bland et al. 2014)
Quma	Antacid - antacid suspension	Each 5ml contains: Magnesium Hydroxide 106 mg; Preservative: Sodium Benzoate 0,1 %	No data found
Bonnycare	Herbal remedy for Anti-spasmodic & Colic	Tinospora cordifolia 1 mg Emblica officinalis 0.5 mg Capparis spinose 0.5 mg Piper longum 0.5 mg Foeniculum vulgare 1 mg Cichorium intybus 0.5 mg Cassia occidentalis 0.5 mg Terminalia chebula 0.5 mg Elettaria cardamomum 0.5 mg Glycyrhiza glabra 0.5 mg Anethum graveolens 0.0018 ml Sucrose 1 750 mg Preservatives: Bronopol 0.03 % m/m Methylparaben 0.23 % m/m Propylparaben 0.03 % m/m	Limited studies (6) Low to Medium quality evidence with biased results. Herbal agents were associated with reductions in crying duration compared with placebo or no treatment, and with improvement in symptoms, compared with placebo. However, the quality of the evidence is low or moderate. Researchers reported some side effects in relation to herbal agents, such as constipation, vomiting and inappetence, which, again, limits our confidence in their use. (The Cochrane Collaboration, 2016)
Spasmopep Junior Drops	Herbal remedy	Per 1ml: a) Achillea millefolium herba (Yarrow) extract 49,8 mg b) Marticaria chamomilla flos (Chamomile) extract 49,8 mg c) Anethum graveolens (Dill) Seed oil 1,92 mg d) Foeniculum vulgare (Fennel) oil 1,92 mg e) Aniseed oil 1,56 mg f) Lavender oil 0,96 mg. Inactive ingredients: Glycerine, Potassium sorbate, Sodium Benzoate, Cetomacrogol
Colic Calm	Herbal remedy for crying and fussiness	Activated Charcoal, Sloe Bud Extract, Caraway Seed Extract, Chamomile Flower Extract, Fennel Seed Extract, Ginger Root Extract, Lemon Balm Leaf Extract, Peppermint Leaf Extract. Other Ingredients: Water, Xylitol, Glycerin, Citric acid. Preservatives: Benzoic acid, Potassium Sorbate, Xanthan gum, Potassium Citrate
FeelGood Health Colic Calmer	Homeopathic remedy for infant colic, digestive comfort and teething	Chamomilla (6C), Mag Phos (6C), Lactose (inactive ingredient)	Unlikely to be effective, they may be harmful. Labels of homeopathic products may not report all of the ingredients, some of which potentially may be toxic F1000Research 2018).
Bennets Colic mixture	Antihistamine and sedative mainly used to treat allergies, insomnia, and symptoms of the common cold	Diphenhydramine hydrochloride (3,125mg/5ml) and belladonna tincture (0,125ml/5ml).	Found to be non-effective in nighttime waking. (Arch Pediatr Adolesc Med . 2006 Jul) Not recommended for use in children younger than 12 years, due to severe drowsiness. (WebMD.com)
Lennon’s Behoedmiddel vir kinders	Herbal remedy	Light magnesium carbonate - 210.00 mg. Prepared chalk - 79.85 mg. Contains sugar: sucrose - 1.325g. Alcohol (100%) - 6.48% v/v.	No clinical studies have been conducted on the efficacy of calcium carbonate and magnesium carbonate for infant colic. The possible perceived effectiveness is because of the alcohol content, which may induce sleep and relaxation in the infant (Bland et al. 2014) Sucrose containing products have limited studies (1) with very low-quality evidence, and highly biased results. (The Cochrane Collaboration, 2016)

Product names are listed purely for educational purposes and do not constitute any endorsements. Products are listed in no specific order. Information sourced from the internet, product listings and physical containers.

References:

Biagioli, E. et al. (2016) ‘Pain-relieving agents for infantile colic’, Cochrane Database of Systematic Reviews, 2016(9). doi:10.1002/14651858.cd009999.pub2.
Di Gaspero, N.C. et al. (2019) ‘Perceived effectiveness of complementary medicine by mothers of infants with colic in Gauteng’, Health SA Gesondheid, 24. doi:10.4102/hsag.v24i0.1175.
Merenstein, D. et al. (2006) ‘The trial of infant response to diphenhydramine’, Archives of Pediatrics & Adolescent Medicine, 160(7), p. 707. doi:10.1001/archpedi.160.7.707.
Daelemans, S. et al. (2018) ‘Recent advances in understanding and managing infantile colic’, F1000Research, 7, p. 1426. doi:10.12688/f1000research.14940.1.