functional abdominal pain - not otherwise specified irritable bowel syndrome
Conditions
Interventions
This multicentre study starts with a baseline observation period of four weeks
in which patients are treated according to the first line of treatment for IBS
or FAP-NOS. This standard medical therap
Sponsors
Academisch Medisch Centrum
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: All children aged between 12 and 18 years diagnosed with irritable bowel syndrome or functional abdominal pain - not otherwise specified according to the Rome lV criteria and where informed consent, given by both parents and by children aged 12 years and older, is available, will be invited to participate. The Rome lV criteria form the internationally accepted standard for defining functional gastrointestinal disorders like irritable bowel syndrome and functional abdominal pain-not otherwise specified. 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 fecal calprotectin. Finally, according to a recently published guideline by the Rome Foundation for the design of pharmacological clinical trials in children, patients are required to have an average daily pain rate of >=2 on the Wong Baker Faces Pain Scale
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Current treatment by another health care professional for abdominal symptoms • Previous use of mebeverine • Known hypersensitivity to the active substance or to any of the excipients (magnesium stearate, polyacrylate dispersion, talc, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion, glycerol triacetate, gelatine, titanium dioxide (E171), shellac (E904), propylene glycol, ammonia solution (concentrated), potassium hydroxide, iron oxide black (E172)). • Known diagnosis of cystic fibrosis • Known diagnosis of porphyria • Known concomitant organic gastrointestinal disease • Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, domperidone, and Iberogast (current use of drugs which influence gastrointestinal motility may be met as long as the subject is on a stable dose and the dose will not be adjusted during the study. • Insufficient knowledge of the Dutch language • Known pregnancy or current lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of patients with at least 50% reduction of their abdominal pain intensity and frequency at the end of treatment (12 weeks). The main goal in the treatment of patients with IBS or FAP-NOS is reduction of abdominal pain and therefore pain is our primary outcome. Severity of abdominal pain will be assessed using a diary card, on which patients record daily intensity on a 6 point Likert scale and frequency of abdominal pain episodes during a period of 7 consecutive days. Recording of pain during 7 days is elaborate, but has the benefit that the problem of individual variability in symptoms over time will be reduced. This 7-day diary recording will be done (I) at the start of the baseline period, (II) in the fourth week of the study (start of treatment), (III) in the eight week, (IV) at the twelfth week (end of treatment) and (V) four weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of this study are to investigate the effect of mebeverine on other outcome parameters such as adequate relief, quality of life, depression and anxiety scores, and school absenteeism in children, to investigate the effect of reassurance, explanation and simple dietary and behavioural advice, to study the influence of labelling on the effect of both mebeverine and placebo on pain scores, to study the effect of mebeverine on the faecal gut microbiota composition and to determine the safety of mebeverine in children with irritable bowel syndrome or functional abdominal pain - not otherwise specified. These secondary outcomes will be measured at the start of the baseline period and at the end of treatment. | — |
Countries
Netherlands
Outcome results
None listed