Functional Gastrointestinal Disorders (Irritable Bowel Syndrome or Functional Abdominal Pain - not otherwise specified) MedDRA version: 20.1 Level: LLT Classification code 10064907 Term: Functional abdominal pain System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Duspatal
Product Name: Mebeverine
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 IV criteria will be invited to participate. The Rome IV criteria form the internationally accepted standard for defining functional gastrointestinal disorders like irritable bowel syndrome and functional abdominal pain – not otherwise specified.1 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), fecal screening on Giardia lamblia if patient presents with diarrhea, and on calprotectin in case an Inflammatory Bowel Disease is suspected. The need for further diagnostic testing is left to the discretion of the treating physician. 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. This is a validated pain scale to measure pain intensity. In addition, Informed Consent by both parents and by children aged = 12 years is a necessity before children can be included in the study. Rome IV criteria for irritable bowel syndrome (IBS) in children and adolescents: Diagnostic criteria* must include all of the following: - Abdominal pain at least 4 days per month associated with one or more of the following: a. Related to defecation b. A change in frequency of stool c. A change in form (appearance) of stool - In children with constipation, the pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome) - After appropriate evaluation, the symptoms cannot be fully explained by another medical condition * Criteria fulfilled for at least 2 months before diagnosis Rome IV criteria for functional abdominal pain – not otherwise specified (FAP-NOS) in children and adolescents: Diagnostic criteria* must be fulfilled 4 times per month and include all of the following: 1. Episodic or continuous abdominal pain that does not occur solely during physiologic events (e.g., eating, menses) 2. Insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine 3. After appropriate evaluation, the abdominal pain cannot be fully explained by another medical condition. * Criteria fulfilled at least 2 months before diagnosis. Are the trial subjects under 18? yes Number of subjects for this age range: 284 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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. • Insufficient knowledge of the Dutch language • Known pregnancy or current lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of this study is to determine the effect of mebeverine on abdominal pain intensity and frequency in children with irritable bowel syndrome or functional abdominal pain - not otherwise specified. ;Secondary Objective: 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 with irritable bowel syndrome or functional abdominal pain. To study the influence of labelling on the effect of both mebeverine and placebo on pain scores. To investigate the effect of reassurance, explanation and simple dietary and behavioural advice on abdominal pain intensity and frequency in children with irritable bowel syndrome or functional abdominal pain. To determine the safety of mebeverine in children with irritable bowel syndrome or functional abdominal pain. To study the effect of mebeverine on the faecal gut microbiota composition.;Primary end point(s): The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency after 8 weeks of drug therapy;Timepoint(s) of evaluation of this end point: Twelve weeks and sixteen weeks after start at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in Quality of Life Change in depression and anxiety score Number of school absences during the treatment Use of pain rescue medication during the treatment (like paracetamol or NSAIDs) Health status Somatisation scores Expectancy of the treatment Change in IBS/ FAP symptoms on a 7 point scale (IBS-GAI) Adequate relief Effect of positive labelling Microbiota composition Safety of mebeverine use ;Timepoint(s) of evaluation of this end point: In the week before the start of the study, in the fourth week of the study, in the eight week of the study, in the twelfth week of the study and in the sixteenth week of the study. | — |
Countries
Netherlands
Contacts
Public ContactMarc Benninga
Academic Medical Center
Outcome results
None listed