Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

March 16, 2021

Primary Completion Date

March 16, 2022

Study Completion Date

December 31, 2023

Conditions
Constipation - Functional
Interventions
DIETARY_SUPPLEMENT

Manna

"Administration is by the oral route according to weight at a dosage of 1 g/kg/day, dissolved in a glass of water, up to a maximum of 30 g. Administration should be repeated every 24 h for 8 weeks, accompanied by plenty of hydration.~In case an effective dosage is achieved (evacuation within 72 h) it will be maintained until the end of the study. If evacuation has not occurred after 72 h, evacuative enema and increased dosage to 1.5 g/kg/day will be indicated. If further evacuative enema is needed, product administration will be discontinued and classical polyethylene glycol therapy will be started as per guidelines."

Trial Locations (1)

15121

SC Pediatria, Alessandria

All Listed Sponsors
collaborator

Iuppa Industriale S.r.l.

UNKNOWN

lead

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

OTHER

NCT06404853 - Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation | Biotech Hunter | Biotech Hunter