Refractory Irritable bowel Syndrome Healthy volunteers Adolescents Fecal transplantation
Conditions
Interventions
Bowel lavage with Klean-Prep
Faecal transplantation by nasoduodenal tube infusion
Venapunction
Sponsors
Academic Medical Center, Amsterdam
Eligibility
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 o Before inclusion, all patients undergo routine laboratory testing to exclude underlying organic disorders: complete blood cell count, C-reactive protein, celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin. The need for further diagnostic testing is left to the discretion of the treating physician. • According to a recently published guideline by the Rome Foundation for the design of pharmacological clinical trials in adolescents, patients are required to have an average daily pain rate of at least 30mm on the pain component scale 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 fibre intake and a decrease in gas producing foods • Absence of response to a minimum of six sessions of psychological treatment (i.e. cognitive behavioural 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 ≥18 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 • 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 known malignant disease and/or patients who are receiving systemic anti-neoplastic agents • Known psychiatric disease (depression, schizophrenia, autism, Asperger’s syndrome) • Known 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 or known exposure within recent 12 months, 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 Campylobac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To investigate the effect of two healthy donor faeces infusion (allogeneic) in comparison to two infusions with own faeces (autologous) on: 1. Intra-individual changes in faecal gut microbiota composition 2. Safety of faecal microbiota transplantation in patients with irritable bowel syndrome 3. Decrease in IBS complaints, assessed by abdominal pain frequency and intensity, after 6 and 12 months 4. Total IBS-SSS score 5. Health-related quality of life (HRQOL) 6. Depression and anxiety scores 7. Adequate relief 8. Absence of school or work, use of health care resources and additional costs 9. Safety parameters | — |
Contacts
Public ContactJ. Zeevenhooven
Outcome results
None listed