To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

Ipsen88 enrolled

Overview

The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Constipation

Interventions

PEG 4000 (Forlax®)DRUG

Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.

Lactulose active and Lactulose placeboDRUG

Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis) * Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy Exclusion Criteria: * Organic bowel diseases * Suspected GI obstruction * History of GI surgery

Locations (2)

Ramathibodi Hospital, Mahidol University,

Bangkok, Thailand

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, Thailand

Outcomes

Primary Outcomes

Bowel movement frequency

Time frame: week 4

Secondary Outcomes

Subjective symptoms associated with defecation.

Time frame: At every visit

Data from ClinicalTrials.gov

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