Lactase vs APT198K for Baby Colic Relief

clinical-trial PMID: 28114795

Lactase vs APT198K for Baby Colic Relief

Quick Summary: A 2017 pilot study tested lactase supplements against APT198K—a mix of plant fiber and heat-killed good bacteria—for easing infant colic symptoms. Both helped reduce crying in 46 babies, but APT198K cut crying time per episode more effectively by day 8, with benefits lasting until day 11. This suggests APT198K might work better than lactase for colicky infants, though more research is needed.

What the Research Found on Lactase for Infant Colic

Infant colic causes excessive crying in babies, often due to tummy troubles like gas or digestion issues. Lactase is an enzyme that breaks down lactose (milk sugar) to help with lactose intolerance symptoms. In this study, researchers compared it to APT198K for treating colic.

Key results showed:
- Both treatments reduced the number and length of crying episodes compared to the start of the study.
- By day 8, babies on APT198K cried for shorter times per episode (about 9 minutes on average) than those on lactase (about 13 minutes). This difference was statistically significant (p=0.014), meaning it's unlikely due to chance.
- The shorter crying lasted until day 11, even after stopping treatment on day 10.
- No major safety issues were reported for either, but the study focused more on effectiveness.

These findings highlight that while lactase helps with colic, a combo like APT198K (xyloglucan fiber plus heat-killed Lactobacillus reuteri and Bifidobacterium brevis bacteria) might provide stronger relief by supporting gut health.

Study Details

This was a small, randomized trial across multiple centers in Europe, registered as EudraCT 2014-002860-334.

Who was studied: 46 healthy infants aged 3 to 16 weeks with diagnosed infantile colic (crying more than 3 hours a day, at least 3 days a week).
How long: Babies took the treatment for 10 days, with check-ins from day 1 to day 11 to track crying patterns.
What they took: Infants got either APT198K (a oral supplement with plant-based fiber and inactive probiotics) or a standard lactase dietary supplement (enzyme drops to aid milk digestion). Exact doses weren't detailed, but both were given orally as first-line treatments.

What This Means for You

If your baby has colic, you're likely searching for ways to soothe their cries and get some rest. Lactase supplements can help by tackling potential lactose issues in formula or breast milk, but this study shows APT198K might reduce crying faster and more noticeably after about a week.

For parents: Talk to your pediatrician before trying either—lactase is common for dairy-related colic, but APT198K's gut-friendly mix could be an alternative if lactase isn't enough. Always check for allergies or underlying issues.
Real-life tip: Track your baby's crying with a journal to see what works. This research supports exploring enzyme or probiotic options early, but results vary by baby.
Bigger picture: Colic often improves by 3-4 months, so combine treatments with soothing techniques like swaddling or white noise.

Study Limitations

This was a pilot study, so take the results with caution—it's promising but not definitive.

Small group of just 46 babies means it might not apply to all infants.
Open-label setup (everyone knew what treatment was given) could bias parents' reports on crying.
Short 10-day trial doesn't show long-term effects or compare to no treatment (no placebo group).
Details like exact doses were missing, making it hard to replicate at home.

For stronger evidence, larger studies are recommended. Source: PubMed. Consult a doctor for personalized advice.

Key Findings

This pilot study found that APT198K (a combination of xyloglucan, heat-killed Lactobacillus reuteri SGL01, and Bifidobacterium brevis SGB01) significantly reduced crying episode duration in infants with colic compared to a lactase dietary supplement. Both treatments improved outcomes from baseline, but APT198K demonstrated superior efficacy by day 8 (p = 0.014), with effects sustained until day 11. Safety profiles were not detailed in the summary.

Study Design

The study was a randomized, multicenter, open-label, parallel-group, active-controlled clinical trial conducted in 2017. It included 46 infants aged 3–16 weeks diagnosed with infantile colic. Participants were assigned to receive either APT198K or a lactase dietary supplement for 10 days, with outcomes assessed at baseline and throughout the intervention period.

Dosage & Administration

The study used APT198K (specific formulation details not provided in the summary) and a lactase dietary supplement (exact dosage unspecified). Both interventions were administered orally to infants, though the frequency and method (e.g., drops, powder) were not described in the provided details.

Results & Efficacy

Crying duration per episode:
APT198K group: 9.14 ± 5.34 minutes on day 8 vs. lactase group: 13.22 ± 5.29 minutes (p = 0.014).
The difference persisted on day 11 (study conclusion).
Crying frequency: Both groups showed significant within-group reductions from baseline (no between-group comparisons provided).
Statistical significance: The primary endpoint (crying duration) met significance (p < 0.05) for APT198K over lactase.

Limitations

Small sample size (n=46) limits generalizability and statistical power.
Open-label design introduces potential bias due to lack of blinding.
Short duration (10 days) precludes evaluation of long-term efficacy or safety.
Active-controlled design compares APT198K to lactase but lacks a placebo arm to assess standalone efficacy of either treatment.
Unspecified dosages and administration methods reduce reproducibility.

Clinical Relevance

For infants with colic, this study suggests APT198K may be more effective than lactase supplements in reducing crying duration after 8 days of treatment. However, as a pilot trial, these results should be validated in larger, double-blind, placebo-controlled studies. Parents considering probiotic-based interventions should consult pediatricians, as the safety of heat-killed bacteria in infants requires further scrutiny. The findings highlight the potential of multi-strain probiotic formulations over single-enzyme approaches (e.g., lactase) for managing colic symptoms.

Source: PubMed | Trial Registry: EudraCT 2014-002860-334