Irritable Bowel syndrome Functional Abdominal Pain Not otherwise specified
Conditions
Interventions
Trade Name: Tempocol
Product Name: Tempocol
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
St Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children aged between 8 and 18 years • Diagnosis of IBS or FAP-NOS according to the Rome IV criteria • Exclusion of underlying organic disorders after routine laboratory testing initiated by their general practitioner or treating physician as part of standard of care • In patients without alarm symptoms only celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin are necessary.37 In patients with diarrhea faecal testing for Giardia Lambliae will be added. If alarm symptoms are present, further diagnostic testing (like a full blood count, CRP, liver tests or an ultrasound) to rule out an organic disorder, is left to the discretion of the treating physician. • An average daily pain rate of =2 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).36 • Informed Consent by both parents and by children aged = 12 years. No informed consent from parents is necessary for children >16 years. Are the trial subjects under 18? yes Number of subjects for this age range: 240 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: • Current treatment by another health care professional for abdominal symptoms • Previous use of peppermint oil for abdominal complaints • Known hypersensitivity to mints or peppermint oil • Gastrointestinal blood loss • Recurrent or unexplained fevers • Decreased growth velocity • History of previous abdominal surgeries in the past 3 months • Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child’s ability to participate or confound the results of the study • Known concomitant organic gastrointestinal disease • Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, mebeverine and Iberogast. If laxatives are being used (in patients with IBS-C) they can continue using them during the study. • Current use of proton-pump inhibitors • Insufficient knowledge of the Dutch language • Pregnancy or current lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study's primary objective is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules on abdominal pain reduction in children with irritable bowel syndrome or functional abdominal pain- not otherwise specified. ;Secondary Objective: Secondary aims are to study the effect of peppermint oil capsules on other disease-related outcomes. These are recently defined outcome measures for trials in children with chronic abdominal pain: degree of reduction in pain frequency and pain intensity, percentage of patients with adequate improvement of complaints, hours of absenteeism, quality of life, feelings of anxiety & depression, bowel habits, taste, ease of use and side effects of the treatment. ;Primary end point(s): The primary endpoint is the percentage of children showing > 30% reduction in abdominal pain intensity after 8 weeks of treatment from baseline. Abdominal pain intensity will be scored with the Wong-Baker faces scale, during 7 consecutive days, using a smartphone abdominal pain app.;Timepoint(s) of evaluation of this end point: At the end of the treatment, 8 weeks (T2) after baseline (T0). Other time points in this study are halfway treatment (T1 = 4 weeks) and after 4 weeks of follow-up (T3=12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in pain duration: abdominal pain duration will be scored in minutes of abdominal pain per day during 7 consecutive days, using the smartphone abdominal pain app at T0, T1, T2 and T3. • Change in pain frequency: abdominal pain frequency will be scored as the average amount of days with pain during 7 consecutive days, using the smartphone abdominal pain app at T0, T1, T2 and T3. • Change in abdominal pain intensity: abdominal pain intensity will be scored during a period of 7 consecutive days using a 10-point Wong-Baker faces scale, using daily the smartphone abdominal pain app at T0, T1, T2 and T3. • Change in Quality of Life: Quality of life is measured by the Dutch version of the Paediatric Quality of Life Inventory questionnaire (PedsQL 4.0). It will be measured at baseline (T0) and after 8 weeks (T2, end of treatment). • Change in depression and anxiety score: depression and anxiety scores are measured by the Revised Anxiety and Depression Scale-short version (RCADS-25) at T0 and T2. • School absences during the treatment: hours of school absence in the previous are measured by a self-designed questionnaire at T0, T1, T2, and T3. • Use of pain rescue medication during the treatment (like paracetamol or NSAIDs): assessed by the smart phone app, on which patients can record the use of rescue pain medication. It will be measured at T0, T1, T2, and T3. • Expectancy of the treatment: expectations of both parents separately, and the child of the treatment on a scale of 0 (no improvement) to 10 (very much improved) are measured by a self-designed questionnaire at start of baseline period. • Change in defecation pattern: change in defecation pattern is scored using the smart phone app, on which patients can record daily stool frequency and consistency according to the Bristol Stool Scale. This will be measured at T0, T1, T2 and T3. • Adequate relief: patients and parents will be asked whether they/their child has adequate re | — |
Countries
Netherlands
Contacts
Public ContactK. Vermeijden
St Antonius Hospital Nieuwegein
Outcome results
None listed