Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks
研究概览
简要总结
Fasting blood specimens will be taken from the patients with IBS that have inclusion criteria. First, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. They will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. During 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the other placebo form, both of them and placebo of both. At the end, body mass index ( BMI), serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen receptors will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-75 yrs
- •patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria
- •a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery
- •no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs
- •no pregnancy and lactation
- •not athlete or bed rest
- •no history of breast cancer in herself or her family
- •no severe psychosis
排除标准
- •a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study
- •diet changes during study
- •use of artificial sweetener 2 days before study
- •no desire to complete the study
- •adverse effect of supplement
- •pregnancy during study
研究组 & 干预措施
Placebo
Group Placebo receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks
干预措施: Placebo of soy isoflavones (Dietary Supplement)
Cholecalciferol
Group Cholecalciferol receiving oral Placebo in similar form to soy isoflavones (diadzein, genistein, glycitin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks
干预措施: Placebo of soy isoflavones (Dietary Supplement)
Cholecalciferol
Group Cholecalciferol receiving oral Placebo in similar form to soy isoflavones (diadzein, genistein, glycitin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks
干预措施: cholecalciferol (Dietary Supplement)
Placebo
Group Placebo receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks
干预措施: placebo of cholecalciferol (Dietary Supplement)
Soy- Cholecalciferol
Group Soy- Cholecalciferol receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genistein, glycitin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks
干预措施: cholecalciferol (Dietary Supplement)
Soy- Cholecalciferol
Group Soy- Cholecalciferol receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genistein, glycitin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks
干预措施: Soy isoflavones (Dietary Supplement)
Soy
Group Soy receiving placebo similar to 50000 IU cholecalciferol (includes MCT oil) biweekly for 6 weeks in addition to 40 milligram (2 capsules per day) soy isoflavones capsules for 6 weeks
干预措施: placebo of cholecalciferol (Dietary Supplement)
Soy
Group Soy receiving placebo similar to 50000 IU cholecalciferol (includes MCT oil) biweekly for 6 weeks in addition to 40 milligram (2 capsules per day) soy isoflavones capsules for 6 weeks
干预措施: Soy isoflavones (Dietary Supplement)
结局指标
主要结局
Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks
时间窗: 6 weeks
次要结局
- Change of baseline in gut permeability as efficacy at 6 weeks(6 weeks)
- Change of baseline in inflammation status as efficacy at 6 weeks(6 weeks)
- Change of baseline in antioxidant status as efficacy at 6 weeks(6 weeks)
研究者
Mahsa Jalili
Mrs
Shahid Beheshti University of Medical Sciences