Evaluation of the efficacy of Fexofenadine in combination with Mebeverine and Mebeverine with placebo in patients with irritable bowel syndrome

Evaluation of the efficacy of the Fexofenadine as adjunctive therapy to Mebeverine in patients with Irritable bowel syndrome (IBS)

Placebo Controlled Clinical trial (phase 3), Parallel group, Double blind, Randomised

In this study, patients suffering from IBS who are admitted to Day hospital, Firoozgar hospital and Municipal's clinic in Tehran and Dr Parsi Clinic in Ahvaz and have the inclusion criteria, will enter to the study. Patients will be divided randomly in two groups. In the intervention group, Fexofenadine tablet 180 mg/day and in control group one placebo tablet a day will be added to the main treatment regimen for 4 weeks. Abdominal pain (severity of pain and Duration of pain),Abdominal distension (bloating,swollen or tight tummy), Satisfaction with fecal excretion, Improving patients symptoms and Quality of life is assessed by the questionnaire before the intervention and one months after the intervention and will be completely reviewed at the end of the study.

Inclusion criteria: 1. Patients with Irritable Bowel Syndrome based on Rome IV Criteria 2. Age between 18-65 years old 3. Informed consent. Exclusion criteria: 1. Patients with Diabetes, Cardiovascular Diseases, Neurological and Psychiatric Disorders, Hepatic Disorders, Renal Failure, Celiac and Colitis 2. Pregnancy and Lactation 3. History of Drug Allergy

In intervention group, patients will receive Mebeverine 200 mg once daily and Fexofenadine tablet 180 mg/day for 4 weeks and in Control group, patients will receive Mebeverine and placebo for 4 weeks.

Abdominal pain (severity of pain and duration of pain); Abdominal distension (bloating, swollen or tight tummy); Satisfaction with fecal excretion; The impact of the IBS on the Patient's Quality of Life; Irritable Bowel Syndrome Severity Score

Random number table: Two groups of 30 patients were made using simple randomization method, based on Random Sequence Generator via www.random.org website. For Random Allocation concealment, the method of opaque sealed envelopes with random sequence was used. Patients were allocated in one of two groups based on their entry sequence.

In this study both researcher and patients are not aware which medication the patient is using. Drugs will be dispensed by researcher in uniform packages with codes. Placebo tablets are quite similar in color and shape to the drug.

Information about the primary outcome will be shared after Deidentification of Individual Participant Data

after publication of paper,for two years

Academic persons

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