A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.
A randomized controlled trial (Phase IV trial) to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic (otilonium bromide) agent for 470 newly diagnosed or newly treated irritable bowel syndrome patients in primary care. The primary objective of this trial is to study treatment efficacy (IBS-SSS responder rate) with diet versus medication after 8 weeks of therapy. The secondary endpoint is to study the quality of life and health economic impact over six months after the start of the initial treatment with diet versus medication. Finally, patient satisfaction during and after the different treatment modalities, HRU and WPAI-IBS score in subgroups according to IBS stool pattern subtype, faecal microbiota and serotonin synthesis genetic polymorphisms will also be investigated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
472
Patients will be randomized to a diet or a mediation treatment
Patients will be randomized to a diet or a mediation treatment
Univeristy Hospital Leuven
Leuven, Vlaams-Brabant, Belgium
Treatment efficacy of symptom severity
IBS-SSS: IBS symptom severity score The maximum achievable score is 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and \>300 respectively. Controls scored below 75 and patients scoring in this range can be considered to be in remission. Efficacy of treatment will be assess by calculating the proportion of patients in each arm with a drop of 50 points or more on the IBS-SSS. The higher the drop, the more the patient has improved.
Time frame: 1.5 year
Treatment efficacy in quality of life
Assessment will be done with the IBS-QoL questionnaires before and during the study. This includes IBS generic functional status and well-being, perceived quality of life specific to IBS, and work disability. Quality of life and health economic impact over 6 months after the start of the initial treatment with diet versus medication will be studied. Questionnaire includes a 5-point Likert response scale: not at all, slightly, moderately, quite a bit, and extremely or a great deal. All items were sum-scored to calculate total scores.
Time frame: 1.5 year
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