Trial · NCT05799053
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Abdominal pain intensity response rate after 8 weeks of treatment | 8 weeks | The proportion of patients with ≥ 30% reduction of their abdominal pain intensity after 8 weeks of therapy compared to baseline. This will be assessed by a smartphone diary app, on which patients record daily at the end of the day the intensity of their abdominal pain during a period of 7 consecutive days using a 10 point Likert scale/Wong-Baker faces scale. A score of 0 correlates with no pain and a score of 10 correlates with the worst imaginable pain. The intensity scores of 7 days will be summed up. |
| Secondary | Change in pain duration | 4 weeks, 8 weeks, 12 weeks | Abdominal pain duration will be scored in minutes of abdominal pain per day during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in pain frequency | 4 weeks, 8 weeks, 12 weeks | Abdominal pain frequency will be scored as the average amount of days with pain during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in abdominal pain intensity | 4 weeks, 8 weeks, 12 weeks | Abdominal pain intensity will be scored using a 10-point Wong-Baker faces scale during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in Quality of Life | 8 weeks | Change in quality of live will be measured with the PedsQL after 8 weeks of therapy compared to baseline |
| Secondary | Change in depression and anxiety score | 8 weeks | Depression and anxiety scores are measured by the Revised Anxiety and Depression Scale-short version (RCADS-25) after 8 weeks of therapy compared to baseline |
| Secondary | School absences during the treatment | 4 weeks, 8 weeks, 12 weeks | Hours of school absence in the previous week are measured. |
| Secondary | Use of pain rescue medication during the treatment | 4 weeks, 8 weeks, 12 weeks | Use of pain rescue medication like paracetamol or NSAIDs |
| Secondary | Expectancy of treatment | 0 weeks | expectations of both parents separately of the treatment on a scale of 0 (no improvement) to 10 (very much improved) |
| Secondary | Expectancy of treatment | 0 weeks | the child's expectations of the treatment on a scale of 0 (no improvement) to 10 (very much improved) |
| Secondary | Change in defecation pattern | 4 weeks, 8 weeks, 12 weeks | Change in defecation pattern is recorded as the daily stool frequency and consistency according to the Bristol Stool Scale |
| Secondary | Adequate relief | 4 weeks, 8 weeks, 12 weeks | patients will be asked whether they have adequate relief of IBS/FAP-NOS symptoms using a single question ("Did you have adequate relief of IBS/FAP-NOS symptoms (abdominal discomfort/pain, bowel habits, and other symptoms like nausea and bloating) over the past week?") scored on a dichotomous scale (Yes/No) |
| Secondary | Health status | 8 weeks | the EQ-5D-Y is a standardised questionnaire on health-related quality of life and will be used in the cost-effectiveness and cost-utility analysis |
| Secondary | Costs | 8 weeks, 12 weeks | iMCQ and the iPCQ will be used to measure the direct and indirect costs due to health care utilization and work absenteeism by parents |
| Secondary | Safety of peppermint oil | 4 weeks, 8 weeks, 12 weeks | incidence of adverse events will be reported by the participants |
| Secondary | Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets | 8 weeks | Ease of use of capsules or sweets will be scored after 8 weeks using a 5-point Likert scale with the following statement: the pills were easy to use and swallow: strongly disagree/disagree/neither agree nor disagree/agree/strongly agree. |
| Secondary | Taste of peppermint oil capsules, placebo capsules or peppermint sweets | 8 weeks | taste of capsules or sweets will be scored after 8 weeks using a Likert scale: I like the taste of the pills: strongly disagree/disagree/neither agree nor disagree/agree/strongly agree. |
| Secondary | Placebo genes | 0 weeks | Several other single nucleotide polymorphisms (SNPs) were found to influence response to placebo treatment. Therefore, we will investigate whether SNPs in a candidate set of genes (previously associated with either the placebo response in adults) are related to either placebo response or treatment response in children with IBS or FAP-NOS. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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