Multicentre, Randomised, Placebo-Controlled Trial of Mebeverine in Children with Irritable Bowel Syndrome (IBS) or Functional Abdominal Pain- Not Otherwise Specified (FAP-NOS)
- Conditions
- functional abdominal pain - not otherwise specifiedirritable bowel syndrome10017977
- Registration Number
- NL-OMON55563
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 284
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the proportion of patients with at least 50% reduction<br /><br>of their abdominal pain intensity and frequency at the end of treatment (12<br /><br>weeks). The main goal in the treatment of patients with IBS or FAP-NOS is<br /><br>reduction of abdominal pain and therefore pain is our primary outcome. Severity<br /><br>of abdominal pain will be assessed using a diary card, on which patients record<br /><br>daily intensity on a 6 point Likert scale and frequency of abdominal pain<br /><br>episodes during a period of 7 consecutive days. Recording of pain during 7 days<br /><br>is elaborate, but has the benefit that the problem of individual variability in<br /><br>symptoms over time will be reduced. This 7-day diary recording will be done (I)<br /><br>at the start of the baseline period, (II) in the fourth week of the study<br /><br>(start of treatment), (III) in the eight week, (IV) at the twelfth week (end of<br /><br>treatment) and (V) four weeks after the end of treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes of this study are to investigate the effect of mebeverine on<br /><br>other outcome parameters such as adequate relief, quality of life, depression<br /><br>and anxiety scores, and school absenteeism in children, to investigate the<br /><br>effect of reassurance, explanation and simple dietary and behavioural advice,<br /><br>to study the influence of labelling on the effect of both mebeverine and<br /><br>placebo on pain scores, to study the effect of mebeverine on the faecal gut<br /><br>microbiota composition and to determine the safety of mebeverine in children<br /><br>with irritable bowel syndrome or functional abdominal pain - not otherwise<br /><br>specified. These secondary outcomes will be measured at the start of the<br /><br>baseline period and at the end of treatment. </p><br>