Lactase Drops Ease Baby Colic Crying

clinical-trial PMID: 35922776

Lactase Drops Ease Baby Colic Crying

Quick Summary: A clinical trial tested oral lactase drops on infants with colic, a condition causing excessive crying in the first few months of life. Babies given lactase cried or fussed for nearly half as long each day compared to those on a placebo, and they had fewer bad colic days. Parents felt more satisfied with the treatment, and it was safe with no major side effects.

What The Research Found

This study showed that lactase, an enzyme that helps break down lactose (a sugar in milk), can make infantile colic better. Infantile colic means a healthy baby cries a lot for no clear reason, often more than 3 hours a day, several days a week.

Key results include:
- Babies on lactase had an average of 89.9 minutes of crying or fussing per day after 4 weeks, compared to 178.5 minutes for those on placebo—a big drop of about 88 minutes.
- The lactase group had colic episodes lasting over 3 hours on only 12.1 days during treatment, versus 17.6 days in the placebo group.
- Parents of babies on lactase reported higher satisfaction with how their child's symptoms improved.
- Side effects were similar in both groups (about 12-15% of babies had minor issues like spit-up or rash), showing lactase was just as safe as the fake drops.

These findings suggest lactase might help by easing any trouble digesting milk sugar, though the study didn't directly test that.

Study Details

Who was studied: 162 healthy infants under 5 months old (average age about 2 months) from an urban hospital in Delhi, India. All met standard medical rules for diagnosing colic, like crying over 3 hours a day at least 3 days a week.
How long: The trial lasted 4 weeks, with check-ins at the start and end to measure crying time and colic days.
What they took: Babies in the treatment group got 5 drops of lactase (containing 600 FCC units per milliliter, a measure of enzyme strength) mixed into breast milk or formula, given 4 times a day. The placebo group got identical-looking drops without lactase. Neither parents nor doctors knew who got the real thing (double-blind setup) to keep results fair.

What This Means For You

If your baby has colic and cries endlessly, this research points to lactase drops as a simple option to try under a doctor's guidance. It could cut crying time in half, giving you more rest and less stress—parents in the study felt happier with the results. Always talk to your pediatrician first, especially if your baby is breastfed or formula-fed, to check if lactase fits your situation. It's not a cure-all, but it offers evidence-based relief without extra risks.

Study Limitations

Keep these in mind when thinking about the results:
- It was done at one hospital in India, so findings might differ for babies in other places with different diets or cultures.
- Crying times came from parent reports, which can vary, though the blind setup helped reduce bias.
- The study only lasted 4 weeks, so we don't know if benefits stick around longer.
- It didn't prove exactly why lactase works—maybe not all colic is from lactose issues.
- More research is needed for babies from diverse backgrounds or feeding types.

Source: PubMed | Trial Registration: CTRI/2017/12/010930

Key Findings

This study found that oral lactase supplementation significantly reduced daily crying or fussing time and the number of colic days in infants under 5 months old. Lactase-treated infants experienced 89.9 minutes/day of crying/fussing versus 178.5 minutes/day in the placebo group (p=0.001), and fewer days with colic lasting >3 hours (12.1 vs 17.6 days; p<0.001). Parental satisfaction was higher in the lactase group, with no significant differences in adverse events between groups.

Study Design

A randomized, double-blind, placebo-controlled clinical trial conducted at an urban hospital in Delhi, India. 162 infants (mean age 63.5 ± 30.5 days) meeting Rome-IV criteria for infantile colic were enrolled. Participants received lactase drops or placebo for 4 weeks, with outcomes measured at baseline and post-treatment.

Dosage & Administration

The intervention group received 5 drops (600 FCC units/mL) of lactase enzyme mixed with breast milk or formula feed, administered four times daily. The placebo group received identical drops without lactase. Treatment duration was 4 weeks.

Results & Efficacy

Crying/fussing time: Lactase reduced mean daily duration by 88.6 minutes (89.9 ± 115.2 vs 178.5 ± 153.2; p=0.001).
Colic days (>3h/day): Lactase group had 12.1 ± 7.8 days vs 17.6 ± 8.4 days in placebo (p<0.001).
Parental satisfaction: Significantly higher in lactase group (data not quantified numerically).
Safety: Adverse events occurred in 12.5% (lactase) vs 14.6% (placebo) (p=0.74), indicating comparable tolerability.

Limitations

Single-center design: Results may not generalize to other populations or settings.
Parent-reported outcomes: Subjective measures could introduce bias, though blinding mitigated this partially.
Short duration: Effects beyond 4 weeks were not assessed.
Demographic specificity: Participants were from an urban Indian hospital; cultural or dietary factors (e.g., breastfeeding practices) might influence results.
Mechanistic uncertainty: The study did not measure lactose malabsorption directly, leaving the exact mechanism of action unclear.

Clinical Relevance

For caregivers of infants with colic, oral lactase drops may offer a safe, evidence-based option to reduce crying/fussing duration and improve satisfaction. The 600 FCC units/mL dosage used in this trial provides a reference for clinical application. However, consultation with a pediatrician is critical before use, as individual responses may vary. These findings support lactase as a potential therapeutic tool in colic management, though further research is needed to confirm efficacy across diverse populations and feeding types.

Source: PubMed | Trial Registration: CTRI/2017/12/010930