Quick Answer: Infantile colic, the most common cause of inconsolable newborn crying, is defined by the Wessel "Rule of 3s": crying for more than 3 hours a day, more than 3 days a week, for more than 3 weeks, in an otherwise healthy infant (StatPearls, NCBI Bookshelf, 2023). It affects an estimated 1 in 5 infants, is self-limiting, and resolves on its own in about 90% of babies by 4 months. The good news for exhausted parents: while no single trick "cures" colic, three approaches have real evidence behind them. They are, in order of how directly they are studied: adjusting feeding position and burping to reduce swallowed air, the 5 S's calming technique developed by paediatrician Dr Harvey Karp, and, for breastfed babies, the probiotic Lactobacillus reuteri DSM 17938, which reduced average crying time by about 25 minutes a day in a 2018 meta-analysis of 345 infants (Sung et al., Pediatrics, 2018). Things that do not have good evidence include simethicone drops and routine formula switches.
What colic is: Crying that fits the Rule of 3s, in a baby who is otherwise healthy and feeding well (StatPearls, 2023).
How common, and how long: Around 1 in 5 infants, with estimates ranging from 5% to 40% depending on the definition. It typically starts in the second week, is heaviest in the first six weeks, and resolves in roughly 60% of babies by 3 months and 90% by 4 months.
Intervention 1, feeding and burping: Swallowed air (aerophagia) is one proposed driver. A more upright feeding position and frequent burping are low-risk ways to reduce it (Medscape, 2023).
Intervention 2, the 5 S's: Swaddle, side or stomach hold, shush, swing, suck. The most-studied infant-soothing method; its strongest trial showed it eased pain during vaccinations.
Intervention 3, L. reuteri DSM 17938: In breastfed infants, a 2018 meta-analysis found about 25 minutes a day less crying; an earlier meta-analysis found a larger effect (Sung et al., 2018; Xu et al., PLOS One, 2015). Evidence in formula-fed babies is lacking. Ask your paediatrician first.
What does not have good evidence: Simethicone drops, routine formula changes, and maternal elimination diets, which help only a small minority.
Infantile colic is frequent, intense, inconsolable crying in a baby who is otherwise healthy and feeding and growing well. It was first described in 1954 by paediatrician Morris Wessel, whose "Rule of 3s" is still the most-used definition: crying or fussing for more than 3 hours a day, on more than 3 days a week, for more than 3 weeks (StatPearls, 2023). Many clinicians now drop the 3-week part, because few parents can wait three weeks before seeking help for a distressed baby.
Two facts make colic easier to live with. First, it is common: estimates range widely, from about 5% to 40% of infants, with roughly 1 in 5 a reasonable middle figure. Second, it is self-limiting. Colic usually begins in the second week of life, is heaviest in the first six weeks, and resolves on its own in about 60% of infants by 3 months and 90% by 4 months (StatPearls, 2023). It affects breastfed and formula-fed babies at similar rates.
Honestly, no one fully knows. The leading hypotheses are an immature gut and gut microbiome, immature regulation of the nervous system, and excessive swallowing of air during feeding and crying (Medscape, 2023).
One point is worth clearing up, because it shapes what helps. Gas and colic are not the same thing. A colicky baby often passes gas, but that gas is mostly air swallowed during the crying and feeding, not the underlying cause of the crying. So "treating the gas" is not really treating colic. What the gas connection does tell you is that reducing swallowed air, through feeding position and burping, is a sensible, low-risk thing to try.
This is the first intervention, and it is the lowest-risk one. Aerophagia, the swallowing of air, is one of the proposed mechanisms behind a distended, uncomfortable tummy, and feeding technique is the most direct lever a parent has over it (Medscape, 2023).
Three adjustments make sense. Feed in a more upright position rather than flat, so milk and air separate and the baby swallows less air. Burp frequently, partway through a feed rather than only at the end, for example when switching breasts or every few minutes of bottle feeding. And for breastfed babies, work on a deep latch, since a shallow latch lets in more air; a lactation consultant can help if feeds are difficult. None of these will stop colic on its own, but they cost nothing and carry no risk, which makes them the right place to start.
Gentle tummy massage is something many Indian families do alongside this, and it is a calm, low-risk way to soothe a baby. The Mylo Tummy Roll-On for Baby is a Made Safe certified topical, made with traditional carminative ingredients (hing, saunf, peppermint and olive oil), that some parents use as a vehicle for that massage. It is reasonable to think of it as a comfort and massage aid rather than a treatment: there is no clinical-trial evidence that a topical roll-on relieves colic, gas or reflux, and it should not replace the evidence-backed steps in this article or a paediatrician's advice.
The second intervention is the 5 S's, a soothing technique developed by paediatrician Dr Harvey Karp and introduced in his 2002 book The Happiest Baby on the Block. It is the most-studied non-pharmacological method for calming infant crying.
The idea is that newborns have an innate "calming reflex" that can be switched on by recreating sensations from the womb. The five steps are:
Swaddle: A snug wrap with the arms in, which limits the startle reflex and recreates the womb's close hold.
Side or stomach position: Hold the baby on its side or stomach in your arms. This is for calming only; for sleep, babies must always be placed on their back.
Shush: A loud, steady white-noise sound, roughly as loud as the baby's own crying, imitating the constant whoosh of blood flow in the womb.
Swing: Small, fast, rhythmic jiggling movements while fully supporting the head and neck.
Suck: A pacifier or the breast. If breastfeeding, wait until feeding is well established before offering a pacifier.
How strong is the evidence? The 5 S's are intuitive and widely taught, and the technique has been studied: a randomised study of 230 infants published in Pediatrics found the 5 S's reduced pain and crying during routine vaccinations, and a 2019 study in the Japan Journal of Nursing Science found mothers soothed their babies more effectively after being trained in the method. The honest caveat is that the strongest single trial measured vaccination distress rather than colic specifically, and not every study has been positive. Treat the 5 S's as a genuinely useful calming toolkit, not a guaranteed off-switch.
The third intervention has the most specific clinical evidence, and also the clearest limits. For exclusively breastfed infants, the probiotic strain Lactobacillus reuteri DSM 17938 is the only probiotic with strong meta-analysis support.
The key study is a 2018 individual participant data meta-analysis in Pediatrics, which pooled raw data from 4 double-blind randomised trials covering 345 infants, 174 on the probiotic and 171 on placebo (Sung et al., 2018). At day 21, the probiotic group cried and fussed on average 25.4 minutes a day less than the placebo group (95% CI: 3.5 to 47.3 minutes), and was almost twice as likely to reach treatment success. An earlier 2015 meta-analysis of 6 trials and 423 infants found a larger effect, about 43 to 46 minutes a day less crying at 2 and 3 weeks (Xu et al., PLOS One, 2015).
Two honest qualifications matter here. The effect is real but modest, and the confidence interval is wide, the lower bound is just 3.5 minutes. And the benefit was found in breastfed infants; the evidence for formula-fed infants is lacking, and one community-based trial found no benefit. So L. reuteri DSM 17938 is a reasonable, well-tolerated option to discuss for a breastfed, colicky baby, but it is not a dramatic fix, and you should confirm with your paediatrician before giving any probiotic to a newborn.
|
Approach |
What the evidence shows |
Verdict |
|
Feeding position and frequent burping |
Reduces swallowed air, a proposed mechanism; no risk |
Sensible first step |
|
The 5 S's soothing technique |
Most-studied soothing method; strongest trial eased vaccination pain |
Useful calming toolkit |
|
L. reuteri DSM 17938, breastfed infants |
2018 meta-analysis: about 25 min/day less crying; modest, wide CI |
Best-evidenced option; ask your doctor |
|
Simethicone (anti-gas) drops |
No benefit over placebo in trials |
Not supported by evidence |
|
Routine formula switching |
Not advised unless a specific allergy is diagnosed |
Not routinely supported |
|
Maternal elimination diet |
Helps only a small minority of infants |
Only under medical guidance |
|
Gentle tummy massage / topical roll-ons |
Low-risk and soothing; no trial evidence for treating colic |
Comfort measure, not a treatment |
It is just as useful to know what to skip. Simethicone, the active ingredient in many anti-gas drops, has not outperformed placebo in randomised trials for colic. Routine formula switching, including to lactose-free or specialised formulas, is generally not advised unless a doctor has diagnosed a specific issue such as cow's milk protein allergy (Roberts et al., American Family Physician, 2004). And while a maternal elimination diet helps in cases linked to a genuine cow's milk protein allergy, current evidence suggests dietary changes reduce colic in only a very small minority of infants, so this is something to try only with medical guidance rather than as a default.
The most important message for parents is the one that is easiest to lose at 2 a.m.: colic is not caused by anything you are doing wrong, and it is self-limiting. It resolves in about 90% of babies by 4 months (StatPearls, 2023).
Colic itself is universal, it affects Indian babies at much the same rate as anywhere else. What differs is the response. Indian families have a long tradition of soothing a windy baby with tummy massage, hing (asafoetida) and gripe water. Massage is low-risk and calming. Gripe water and oral remedies are worth more caution: formulations vary, some have historically contained alcohol or other ingredients not suited to newborns, and they are not evidence-backed treatments for colic, so check the label and your paediatrician before using them.
On the evidence side, the probiotic discussed above has been studied specifically in Indian infants. A 2022 real-life, clinic-based study, described by its authors as the first to evaluate L. reuteri DSM 17938 for infant colic in India, reported that average crying time fell substantially over the study and that about 85% of infants achieved at least a 50% reduction in crying (Pediatric Reports, 2022). This was an observational study without a placebo group, so it is weaker evidence than the randomised trials, but it does suggest the strain behaves in Indian infants much as it does elsewhere.
Colic is a diagnosis of exclusion, which means a doctor reaches it only after ruling out other causes. Call your paediatrician if the crying comes with any red-flag sign: fever, vomiting (especially forceful or green), blood in the stool, unusual lethargy, poor weight gain, or a sudden change in feeding (StatPearls, 2023). These point away from simple colic and toward conditions such as infection, reflux or a bowel problem that need medical attention. It is also worth calling if the crying is overwhelming you. Relentless infant crying is a known trigger for parental exhaustion and low mood, and asking for support, medical or personal, is part of looking after your baby too.
At what age does colic start and stop?
Colic typically begins in the second week of life, is at its most intense in the first six weeks, and resolves on its own in about 90% of babies by 4 months of age. Roughly 60% of infants are through it by 3 months (StatPearls, 2023). It affects breastfed and formula-fed babies at similar rates. The single most reassuring fact about colic is that it is self-limiting: it ends, reliably, even when nothing is done, which is why the goal of any intervention is to make the weeks until then more bearable rather than to "cure" anything.
Do probiotics actually work for newborn colic?
For exclusively breastfed infants, the probiotic Lactobacillus reuteri DSM 17938 has real but modest evidence; for formula-fed infants the evidence is lacking. A 2018 meta-analysis of 4 trials and 345 infants found breastfed babies given the probiotic cried about 25 minutes a day less than those on placebo (Sung et al., 2018). It is the best-evidenced probiotic for colic, but the effect is modest and not every trial agreed. Always check with your paediatrician before giving any probiotic to a newborn.
Is gas the same thing as colic?
No. Gas is a symptom, not the cause. A colicky baby passes gas largely because of air swallowed during crying and feeding, but trapped gas itself does not cause the colic syndrome (Medscape, 2023). This distinction is practical: it is why "anti-gas" drops such as simethicone have not worked in trials, and why the genuinely useful step is reducing how much air the baby swallows in the first place, through feeding position and burping.
Is it safe to use a tummy roll-on or massage oil on a newborn?
A topical product formulated for babies and free from harsh ingredients is generally well tolerated, but treat it as a gentle massage aid, not a colic treatment. There is no clinical-trial evidence that a topical roll-on relieves colic, gas or reflux. If you use one, patch test it first on the inner forearm, keep it away from the baby's face and hands, use external skin only, and avoid the navel area until the cord stump has fully healed. The calming part is largely the gentle massage and your touch, both of which are low-risk and soothing.
When should I call the doctor about my baby's crying?
Call your paediatrician if the crying comes with fever, forceful or green vomiting, blood in the stool, unusual sleepiness, poor weight gain, or a sudden change in feeding. These signs suggest something other than colic (StatPearls, 2023). Because colic is diagnosed only after other causes are ruled out, a paediatric check is worthwhile if you are unsure. Call, too, if the crying is wearing you down. Support for the parent is a legitimate and important reason to reach out.
Banks J., Chee J., Rouster A., "Infantile Colic", StatPearls, NCBI Bookshelf, last updated 2023
Medscape, "Colic: Practice Essentials, Background, Pathophysiology", 2023
Karp H., The Happiest Baby on the Block, 2002, for the 5 S's method and the calming-reflex concept. The 5 S's vaccination-distress finding is from a randomised study of 230 infants published in Pediatrics; mother-training evidence is from a 2019 study in the Japan Journal of Nursing Science.
This article is for informational purposes only and does not replace professional medical advice. Consult a qualified paediatrician for guidance specific to your child.
Medically reviewed by Dr Rajan Gupta , MBBS, MD (Pediatric) on 27 May 2026. Last updated: 29 May 2026.
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