Irritable bowel syndrome Spastic colon
Conditions
Interventions
Patients will be randomly allocated to healthy donor LFMCs or placebo (identical capsules with only excipients). After bowel lavage with Klean-Prep, patients will be treated with the capsules with a s
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patienten:Children aged between 8 and 18 yearsDiagnosos of IBS or FAP-NOS according to the Rome IV-criteria.Patients are required to have an average daily pain rate of =2 on the Wong-Baker Faces Pain ScaleInformed consent is required from the parents for children up to 12 years of age. For children between the ages of 12 and 16 years, informed consent must be obtained from both the parents and the children. For children older than 16 years, informed consent is required from the children themselves before they can be included in the study. Donors:Age =18 years, <50 years. Ability to give informed consent BMI 18-25 kg/m2 Regular stool pattern: 3 times per week to 3 times per day with normal consistency, classified as Bristol Stool Chart types 3 or 4.
Exclusion criteria
Exclusion criteria: PatientsCurrent treatment by another health care professional for abdominal symptomsKnown concomitant organic gastrointestinal diseaseAnxiety or depression disorderKnown swallowing disorder or unable to ingest capsules size 0Condition leading to profound immunosuppressionFor example: HIV, infectious diseases leading to immunosuppression, bone marrow malignanciesUse of systematic chemotherapyUse of immune modulators Life expectancy < 12 monthsCurrent use of drugs which influence gastrointestinal motility. If laxatives are being used (in patients with IBS-C) they can continue using them during the study. Pain medication in the form of Paracetamol or NSAIDs is allowedUse of systemic antibiotics in preceding 3 monthsUse of PPI and other antacids in the past 3 months or during the studyUse of probiotic treatment capsules in preceding 3 monthsIn case of diarrhea: positive Dual Feces Test for Giardia lamblia, Entamoeba histolyticaHistory of surgery:Hemicolectomy (defined as: surgery resulting in a resection of > 0.5 of the colon)Presence of a pouch due to surgeryPresence of stomaKnown intra-abdominal fistulaSigns of ileus, diminished passageInsufficient knowledge of the Dutch language DonorsAbnormal defecation pattern (< 3 spontaneous bowel movements per week, hard stools), abdominal complaints or symptoms indicative of irritable bowel syndromeAn extensive travel behaviourSmoking in the past three months or during donation periodHigher risk of colonization with multidrug-resistant organisms including:Persons who have recently been hospitalized or discharged from long term care facilitiesPersons who regularly attend outpatient medical or surgical clinicsPersons who have recently engaged in medical tourism.Unsafe sex practice (questionnaire)Use of any medication, including PPI, in the past 12 weeksAntibiotic treatment in the past 12 weeksHistory of or clinical evidence for inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or other gastrointestinal diseases, including chronic diarrhoea or chronic constipationHistory of or clinical evidence for autoimmune disease (type 1 diabetes, Hashimoto hypothyroidism, Graves hyperthyroidism, rheumatoid arthritis, celiac disease) and/or patients receiving immunosuppressive medicationHistory of or present known malignant disease and/or patients who are receiving systemic anti-neoplastic agentsKnown 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, amoebiasisActive 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:Bacteria:Clostridium difficile, Helicobacter pyloriSalmonella spp., Shigella spp., pathogenic Campylobac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of patients with = 30% reduction of their abdominal pain intensity at t=24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the number of patients with adequate relief after 24 weeks of therapy, changes in pain frequency, defecation pattern, quality of life, depression/anxiety, in school absenteeism, child somatization scores and the incidence of adverse events during the treatment. Furthermore, intra-individual changes in fecal gut microbiota composition and metabolomics are assessed. | — |
Countries
Netherlands
Contacts
Public ContactM.A. Benninga
Amsterdam UMC
Outcome results
None listed