Clinical efficacy and safety of loratadine in treating irritable bowel syndrome with predominant diarrhea

Evaluation the clinical efficacy of Loratadine on GI symptoms of IBS-D patients

A Phase3, randomized, blinded pilot clinical trial with parallel groups design of 32 patients. random allocation process is done by permuted block randomization.

The patients with IBS-D referred to the Omid GI Clinic of Ayatollah Rouhani Hospital are randomly divided into a Loratadine group and a control group. The patients in the Loratadine group receive Loratadine tablets(10mg, oral) once daily and Patients in the control group receive oral Placebo once daily for 4-6 weeks. The patients are followed up once in every 2weeks for 6-8weeks and Gastrointestinal symptoms will be assessed before and after treatment. biographic information, symptoms, response to treatment and adverse drug reactions will be recorded in data collection forms designed for each patient and analyzed. In this study participants, the main researcher, clinicians ,the data collector, and the Data safety and Monitoring Committee are blinded.

Inclusion criteria: Patients with IBS-D؛ Age between 18 and 65؛ No abnormalities observed by Sigmoidoscopy؛ Exclusion criteria: Diabetes؛ Renal impairment؛ Cardiovascular disorders؛ Colitis؛ Celiac disease؛ Use of drugs that affect the digestive system

The patients in the Loratadine group receive Loratadine tablets(10mg, oral) once daily for 4-6 weeks. (if patients do not response to the treatment the dose will be increased to 10mg twice daily).Patients in the control group receive oral Placebo once daily for 4-6 weeks. also all patients receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate).

Diarrhea frequency؛ Pain severity؛ Abdominal pain frequency؛ defecation urgency؛ bloating.

Our study aimed to investigate the efficacy and safety of loratadine in a clinical trial study with 100 patients. According to the coronavirus pandemic, our sampling got into trouble, Our hospital was the COVID-19 patient admission center, on the other hand, most patients didn't get serious their IBS-D disease during the COVID-19 pandemic, so referrals to our GI clinic reduced significantly. Finally, the number of participants had the study inclusion criteria reduced to 40 patients in a year and a half, According to this situation, we request to register our study as a randomized pilot clinical trial Because of our time limitation, if appropriate.

Patients with IBS-D are randomly divided into a Loratadine group and a control group. random allocation process is done by permuted block randomization. 25 Blocks (with 4 subjects per block and AABB permutations) is made by Randomization.com Website and placed on the same drug packages by coding. Letters A and ‌B, the intended permutation and other required information are entered in randomization website. 100 phrases with letters A or B are achieved, which randomly indicate Who should take loratadine and who should take placebo from the first to the hundredth patient,(A=loratadine ,B=placebo).

This is a randomized controlled trial (RCT), In this study, participants, the main researcher, clinicians, the data collector, and the Data Safety and Monitoring Committee are blinded. Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos. The blinded data collector collects data from patients every 2weeks. In the end, the Data collected from both groups are analyzed by data analysts.