Effect of MiniGo as add-on to Oral Laxatives for Children With Constipation and Fecal Incontinence

minigo

The goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (TAI) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence. The main questions it aims to answer are: * Can more efficient treatment be achieved with aforementioned combination therapy? * Does the well-being of the children change, when they are well treated for their symptoms? * Is low-volume trans anal irrigation a tolerable treatment method for children? Participants will be randomized into 2 groups, where one group is treated with current standard treatment of PEG (oral laxatives), and the other group is treated with PEG + daily low volume TAI.

2022-11-01

2024-01-01

2024-01-01

Recruiting

50

Inclusion Criteria: * age 4-14 years * medical history with fecal incontinence \>1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria) * non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use) Exclusion Criteria: * Hirschsprungs disease * anorectal malformations * use of medications known to cause constipation (eg. anticholinergics) * former use of low or high volume TAI or enemas Contraindications for use of MiniGo-irrigation device: * known stenosis of the rectum or intestinal tract * colorectal cancer prior to surgical removal * acute inflammatory bowel disease * acute diverticulitis * within 3 months of surgical procedures in the rectum or intestinal tract * within 4 weeks of endoscopic polypectomy * ischemic colitis

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '50 children randomized into 2 groups. Group a receives current standard treatment, group b receives current standard treatment plus low volume trans anal irrigation as add-on.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-05-11