A randomized study to evaluate the short-term efficacy and long-term health economic impact of diet compared to a medication for patients with irritable bowel syndrome.

Phase 1

• Conditions: Irritable Bowel Syndrome (IBS); relief of abdominal pain, distension and motility disorderscharacterised by smooth muscle spasm.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003258-18-BE
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Eligible patients are those of either gender, above the age of 18, eligible to give informed consent, newly diagnosed with or newly to be treated for IBS in primary care, as this is the setting where the majority of these patients is managed. The diagnostic gold standard, in line with clinical practice, will be clinician’s diagnostic judgment. However, to support the diagnosis and make it more uniform, a Rome IV-based diagnostic questionnaire with pictograms and a list of alarm symptoms will also be included in the CRF at the initial visit, and guidance for diagnosis and potentially useful additional tests will be provided at the investigator meetings, based on the Rome IV management algorithm. Patients who did not receive treatment over the preceding 4 months, and who did not receive long-term treatment (>3 consecutive weeks) with otilonium bromide in the past are eligible for the trial. Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 470
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria applies to the following points:
•Patients not capable to understand or be compliant with the study.
•Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease), a history of major bowel surgery (not including minimal invasive surgery such as appendectomy or cholecystectomy, but including sigmoidectomy, hemicolectomy and small bowel resections)
•Patients who received treatment with otilonium bromide in the past for more than 3 weeks consecutively or who received otilonium bromide recently for any duration in the last 3 months.
•Patients who have used FODMAP or NICE diet before.
•Patients who recently (last 3 weeks) used other medication for IBS, or who changed their diet for IBS or for any other reason over the last 3 months. To be included in the trial patients should stop these treatments following the advice of their GP (see paragraph 8.9).
•Patients with diabetes, uncontrolled thyroid disease, active malignant disease (not including patients with cancer free diagnosis for more than 5 years), symptomatic uncontrolled endometriosis.
•Patients with a major psychiatric disease. The use of a single antidepressant on a stable dose for at least 3 months is allowed (see paragraph 8.9).
•Patients with drug abuse and/or alcohol abuse.
•Patients on pharmacologically prepared probiotic formulations (i.e. bought in the pharmacy) will be excluded. The use of probiotic drinks or yoghurts available from food stores, such as Activia®, Yakult ®, Actimel ®, is allowed but should be registered as complementary treatment”(see paragraph 8.9).
•Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. Also excluded are women of childbearing potential not using effective contraception or women planning to become pregnant the next 6 months (see paragraph 8.9 of the protocol). Methods of contraception considered highly effective are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner or sexual abstinence (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified