FAIS trial; Faecal transplantation in Adolescents with refractory Irritable bowel Syndrome
Recruiting
- Conditions
- Refractory Irritable bowel SyndromeHealthy volunteersAdolescentsFecal transplantation
- Registration Number
- NL-OMON26566
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
Patients
•Age 16-21 years
Exclusion Criteria
Patients
•Current treatment by another health care professional for abdominal symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the effect of repetitive healthy donor faeces infusion (allogeneic) in comparison to infusions with own faeces (autologous) on decrease in IBS complaints, assessed with the pain component of the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score
- Secondary Outcome Measures
Name Time Method To investigate the effect of two healthy donor faeces infusion (allogeneic) in comparison to two infusions with own faeces (autologous) on:<br /><br>1.Intra-individual changes in faecal gut microbiota composition<br /><br>2.Safety of faecal microbiota transplantation in patients with irritable bowel syndrome<br /><br>3.Decrease in IBS complaints, assessed by abdominal pain frequency and intensity, after 6 and 12 months<br /><br>4.Total IBS-SSS score<br /><br>5.Health-related quality of life (HRQOL)<br /><br>6.Depression and anxiety scores<br /><br>7.Adequate relief<br /><br>8.Absence of school or work, use of health care resources and additional costs<br>9.Safety parameters<br /><br><br>