drugset / Trial / NCT05948020

Efficacy and Safety of Orally Administered Engineered Probiotics (CBT102-A) for the Treatment of Children With Phenylketonuria

NCT05948020 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study. A total of 15 children with phenylketonuria(PKU) age 3 to 17 years will be randomized to two groups. Experimental group of 10 children will intervene engineered probiotics (CBT102-A) for 20 days and 5 children will intervene placebo. The goal of this study is to determine whether CBT102-A is an effective and safe treatment for PKU.

Timeline

Start
2023-09-02
Primary completion
2023-11-25
Completion
2024-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject CBT102-A Unknown 1e+12 cells Oral

Indications