Trial of lactose supplementation in CDG

Clinical trial of lactose supplementation in patients with congenital disorders of glycosylation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061200059

Enrollment

Registered

2021-03-04

Start date

2021-03-04

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Congenital disorder of glycosylation

Interventions

Administration of lactose hydrate.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with 1) CDG having the mutation in one of the genes of SLC35A2, PGM1, SLC39A8, or TMEM165. 2) At least one epileptic seizure 28 days prior to the drug administration.

Exclusion criteria

Exclusion criteria: Patients with 1) Dairy allergies. 2) Lactose intolerance. 3) Diabetes mellitus. 4) Severe liver, renal, or cardiac dysfunction. 5) Pregnancy or nursing. 6) Participating in other clinical trials or stidies within three months before enrollment. 7) Judgement to be ineligible for trial.

Design outcomes

Primary

Measure	Time frame
Differences of frequencies of epileptic seizures between baseline and 52 weeks later.	—

Secondary

Measure	Time frame
Variabilities of 1) Epileptic seizures 2) Scores of Nijmegen Pediatric CDG Rating Scale 3) Interictal epileptiform discarges in EEG 4) Serum galactosylglycan	—

Contacts

Public ContactKento Ohta

Tottori University Hospital

neurotaidea@gmail.com+81-859-38-6777

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026