Simethicone is NOT recommended for treating colic in a 13-day-old infant
The best available evidence shows that simethicone is no more effective than placebo for infantile colic and should not be used for this indication. While the 0.3 mL dose you're considering is safe and has been studied, it simply doesn't work for colic symptoms.
Why Simethicone Doesn't Work for Colic
Multiple high-quality randomized controlled trials have definitively shown simethicone's lack of efficacy:
A rigorous double-blind, placebo-controlled multicenter trial of 83 infants found no difference between simethicone and placebo in symptom improvement 1. Parents reported improvement 54% of the time regardless of whether their infant received simethicone or placebo—a classic placebo effect.
Another Scandinavian study confirmed these findings: 67% of infants improved during treatment, but this was entirely attributable to placebo effect with no actual benefit from simethicone 2.
A comprehensive 2016 Cochrane systematic review analyzing multiple studies concluded there is no evidence to support simethicone use for infantile colic 3.
The most recent 2020 systematic review of reviews confirmed moderate to low-quality evidence showing no benefit or even negative effect from simethicone for colic 4.
What Actually Works
Instead of simethicone, consider these evidence-based approaches:
For breastfed infants:
- Lactobacillus reuteri DSM 17938 shows the strongest evidence, reducing crying time by 25-65 minutes per 24 hours 4, 5
- Maternal dietary elimination (removing cow's milk and eggs for 2-4 weeks) if milk protein allergy is suspected 6
For formula-fed infants:
- Trial of extensively hydrolyzed or amino acid-based formula for 2-4 weeks 6
- Bifidobacterium breve BR03 + B632 combination shows preventive benefit 5
General measures that help:
- Keeping infant upright or prone (only when awake and supervised) 6
- Smaller, more frequent feedings 6
- Parental reassurance and education that colic is self-limited and resolves by 4 months 7
Important Caveat About Simethicone
Recent evidence suggests simethicone may actually interfere with other treatments. A 2024 study found that simethicone reduced the efficacy of oral lactase treatment in infants with lactose intolerance 8. This raises concerns about potential drug interactions even with seemingly benign agents.
Red Flags to Watch For
Before attributing symptoms to simple colic, ensure there are no concerning features 9, 7:
- Projectile or bilious vomiting
- Blood in stool or hematemesis
- Fever, lethargy, or poor feeding
- Abdominal distension or tenderness
- Poor weight gain
- Onset after 3 months of age
If any of these are present, further evaluation is needed rather than symptomatic treatment.
Bottom line: Skip the simethicone. It won't help your 13-day-old's colic symptoms. Focus instead on parental reassurance, feeding modifications if appropriate, and consider strain-specific probiotics if symptoms are severe and persistent.