A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

February 1, 2027

Conditions
Constipation - FunctionalConstipationConstipation Aggravated
Interventions
DIETARY_SUPPLEMENT

Actazin chewable tablet

Actazin tablets are tableted non-GMO, freeze-dried, green kiwifruit powder from 100% New Zealand-grown green kiwifruit. Currently, kiwifruit extracts (such as Actazin), are marketed in Canada as a natural supplement. It is safe, bioavailable, and has been previously shown to be well tolerated at doses up to 2400 mg.

DRUG

PEG 3350

a commonly used over the counter laxative in north America. A stool softener.

OTHER

Chewable Tablet

Sorbitol-based placebo chewable tablets made by Pharma NZ. Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets.

OTHER

Maltodextrin (Placebo)

Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group.

Trial Locations (1)

Unknown

Hamilton Health Sciences, Hamilton

All Listed Sponsors
lead

Hamilton Health Sciences Corporation

OTHER

NCT06836024 - A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation | Biotech Hunter | Biotech Hunter