Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- quality of life
研究概览
简要总结
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:
- Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to Amitriptyline (10 mg/HS) for 8 weeks
- Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol (800 mg/ TDS) for 8 weeks
- 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:
- All patients will fulfill an informed consent
- Drugs are available without any charge
- Observation of Helsinki ethical statement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Establishment of diagnosis of IBS by ROME-III criteria
- •Age > 18 years old and < 65 years old
- •Normal colonoscopy or sigmoidoscopy
- •Negative celiac serologic markers
- •Normal complete blood count (CBC) and stool exam and stool culture
- •The patient should not be administered Anti-inflammatory drugs such as Nonsteroidal Antiinflammatory Drugs(NSAIDs), oral or parenteral Antibiotics, Corticosteroids, Mast cell stabilizers, Narcotics, Antidepressants and Immunosuppressive Agents.
- •Normal thyroid-stimulating hormone (TSH )
- •Normal Serum Calcium
- •Educated patient
排除标准
- •Breast feeding and Pregnancy
- •Presence of acute or chronic inflammation which can change the basal level of cytokines
- •Allergic disorders like Asthma (family and personal history)
- •Presence of organic disease like Diabetes mellitus or Psychiatric disorders.
- •Alcohol dependency and addiction to Tobacco and Opium
- •Patients who do not use efficient contraception method
- •History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy, Hysterectomy and Cesarian-Section
- •Presence of Celiac disease
- •History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous year.
- •History of Cardiac, Pulmonary, Hepatic and Renal disease
- •Presence of chronic GI disorders
- •History of Allergy to Aspirin, Mesalamine or Sulpha compounds
- •History of Lymphocytic or Microscopic Colitis
- •History of significant weight loss ( 10% of body weight during 6 months), nocturnal sweating, GI bleeding and family history of Colon cancer
- •Patients with Lactose intolerance disease
- •Presence of Bowel Acid Malabsorption
研究组 & 干预措施
Amitriptyline
patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks
干预措施: Amitriptyline (Drug)
Mesalazine(asacol 800 mg)
patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks
干预措施: Mesalazine(asacol 800 mg) (Drug)
Mesalazine(asacol 800 mg)
patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks
干预措施: placebo like amitriptyline (Drug)
Amitriptyline
patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks
干预措施: placebo like asacol (Drug)
placebo group
patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks
干预措施: placebo like asacol (Drug)
placebo group
patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks
干预措施: placebo like amitriptyline (Drug)
结局指标
主要结局
quality of life
时间窗: 1 year
All patients will fill three validated questionnaires (IBS-SSS , HADS and IBS-QOL ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment to assess quality of life and symptom severity scale in patients with diarrhea- predominant .
次要结局
- Serum immune biomarkers(1 year)