Irritable bowel syndrome
Conditions
Interventions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: • Age 16-21 years • Non-smokers • Ability to give informed consent • Established irritable bowel syndrome diagnosis according to the Rome IV criteria for children or adults • Average daily pain rate of at least 30mm on the pain component of the IBS-SSS • Symptoms are present for >= 12 months • The patient has received adequate explanation and reassurance for his/her symptoms • Appropriate dietary interventions have occurred, including the normalisation of the insoluble fiber intake and a decrease in gas producing foods • Absence of response to a minimum of six sessions of psychological treatment (i.e. cognitive behavorial therapy and/or hypnotherapy) • Absence of response to an adequate dose of at least one IBS specific pharmacological agent tried for a minimum of 6 weeks (like Mebeverine or peppermint oil capsules);Donors: • Age >=16 years • Non-smokers • Ability to give informed consent • BMI 18-25 kg/m2 • Regular stool pattern
Exclusion criteria
Exclusion criteria: Patients: • Current treatment by another health care professional for abdominal symptoms • Known concomitant organic gastrointestinal disease • Known diagnosis of inflammatory bowel disease (i.e. Crohn*s disease or ulcerative colitis) • Known diagnosis of an autoimmune disease (e.g. hypo- or hyperthyroidism, celiac disease, rheumatoid arthritis) • Known diagnosis of cystic fibrosis • Known diagnosis of porphyria • Anxiety or depression disorder • Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, peppermint oil capsules, and Iberogast • Known pregnancy or current lactation • Condition leading to profound immunosuppression o For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies o Use of systematic chemotherapy • Life expectancy 0.5 of the colon) o Presence of a pouch due to surgery o Presence of stoma • Known intra-abdominal fistula • Vasopressive medication, ICU stay • Signs of ileus, diminished passage • Allergy to macrogol or substituents, e.g. peanuts, shellfish • Insufficient knowledge of the Dutch language;Donors: • Abnormal bowel motions, abdominal complaints or symptoms indicative of irritable bowel syndrome • An extensive travel behaviour • Unsafe sex practice (questionnaire) • Use of any medication including PPI • Antibiotic treatment in the past 12 weeks • A positive history/clinical evidence for inflammatory bowel disease (Crohn*s disease or ulcerative colitis) or other gastrointestinal diseases, including chronic diarrhoea or chronic constipation • A positive history/clinical evidence for autoimmune disease (type 1 diabetes, Hashimoto hypothyroidism, Graves hyperthyroidism, rheumatoid arthritis, celiac disease) and/or patients receiving immunosuppressive medications • History of or present malignant disease and/or patients who are receiving systemic anti-neoplastic agents • Psychiatric disease (depression, schizophrenia, autism, Asperger*s syndrome) • Chronic neurological/neurodegenerative disease (e.g. Parkinson*s disease, multiple sclerosis) • Predisposing factors for potential transmittable diseases (e.g. regular sexual contact with prostitutes/promiscuity) • Positive blood tests for the presence of: HIV, HTLV, lues, Strongyloides, amoebiasis • Active hepatitis A, B-, C- or E-virus infection, acute infection with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) • Positive faecal tests for the presence of: o Bacteria: * Clostridium difficile, Helicobacter pylori * Salmonella spp., Shigella spp., pathogenic Campylobacter spp., Yersinia enterocolitica, Aeromonas spp., Plesiomonas shigelloides * Antibiotic resistant bacteria: Extended spectrum beta-lactamase (ESBL)-producin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency at t=12 weeks after the first faecal transplantation, assessed by the pain component of the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Intra-individual changes in faecal gut microbiota composition at baseline, 6 weeks, 12 weeks, 24 and 48 weeks after faecal transplantation - Adverse events (AE) - Decrease in IBS complaints, assessed by abdominal pain frequency and intensity, after 6 and 12 months - Total IBS-SSS score - Health related quality of life - Depression and anxiety - Absence of school or work, health care resources and costs - Adequate relief - Safety parameters - To find patient and microbiota characteristics that predict a positive response to faecal microbiota transplantation. | — |
Countries
Netherlands
Outcome results
None listed