Post-authorization phase IV low-intervention study to evaluate the efficacy under real-world conditions of the use of LacTEST 0.45 g for the diagnosis of hypolactasia in children aged 5 to 11 years presenting symptoms of lactose intolerance.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521294-13-00

Acronym

VPH-GXL-2025-2

Enrollment

164

Registered

2025-06-19

Start date

2025-07-14

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose intolerance

Brief summary

Diagnostic performance (sensitivity, specificity, PPV and NPV) of LacTEST 0.45 g in this pediatric population using the proposed cut-off point of 19.18 mg at 5 hours of urine accumulated.

Detailed description

Diagnostic performance of different cut-off of Xylose to classify pediatric patients as hypolactasic or normolactasic., Diagnostic performance of shortening urine collection to 4 h using the best cut-off for this test., Number and percentage of AEs and its relationship with LacTEST 0.45 g in this pediatric population.

Interventions

DRUGLacTEST 0

DRUG45 g polvo para solución oral.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Diagnostic performance (sensitivity, specificity, PPV and NPV) of LacTEST 0.45 g in this pediatric population using the proposed cut-off point of 19.18 mg at 5 hours of urine accumulated.	—

Secondary

Measure	Time frame
Diagnostic performance of different cut-off of Xylose to classify pediatric patients as hypolactasic or normolactasic., Diagnostic performance of shortening urine collection to 4 h using the best cut-off for this test., Number and percentage of AEs and its relationship with LacTEST 0.45 g in this pediatric population.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026