Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Summary

The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable Bowel Syndrome (IBS-D).

All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) , Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment.

Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for the first time to our private gastrointestinal clinic from 2014 until 2016.

All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for 14 days before inclusion and patients whose symptoms improve by this regimen will be excluded.

This trial is a double-blind study and all patients will be assigned randomly to three groups:

1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to Amitriptyline (10 mg/HS) for 8 weeks
2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol (800 mg/ TDS) for 8 weeks
3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and placebo similar to Amitriptyline (10 mg/HS) for 8 weeks

Ethical considerations:

1. All patients will fulfill an informed consent
2. Drugs are available without any charge
3. Observation of Helsinki ethical statement

Conditions

• Diarrhea- Predominant Irritable Bowel Syndrome
• Quality of Life

Interventions

DRUG

Mesalazine(asacol 800 mg)

DRUG

Amitriptyline

DRUG

placebo like asacol

DRUG

placebo like amitriptyline

Sponsors & Collaborators

• Tillotts Pharma AG

  collaborator INDUSTRY

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Nasser Ebrahimi Daryani, Professor · Tehran University of Medical Science

• Zahra Azizi, Researcher · Iran University of Medical Sciences

• Mohammad Bashashati, Research Associate · University of Calgary

• Nima Rezaei, Assistant Professor · Tehran University Of Medical Science

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Iran

Study Locations