NCT06609746尚未招募不适用
The Effect of Low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides and Polyols) Diet with Thyme on Clinical Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Irritable Bowel Syndrome symptom severity score
研究概览
简要总结
The goal of this clinical trial is to learn if thyme supplement enhances the effects of a low FODAMP diet on reducing clinical symptoms and improving the quality of life of patients with irritable bowel syndrome or not.
The main questions it aims to answer are:
- Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
- Does consumption of thyme increase the quality of life score in patients with irritable bowel syndrome? Researchers will compare thyme supplementation with placebo to see if thyme supplement enhances the effects of a low FODAMP diet on clinical symptoms and quality of life in patients with irritable bowel syndrome.
Participants will:
- Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
- Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
- Visit the clinic at the beginning of the study and the end of the study for a check-up and score record
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Ages 18-65;
- •Patients with irritable bowel syndrome;
- •Body Mass Index in the range of 18-25 kg/m2
排除标准
- •Any organic intestinal disease;
- •Medical history of chronic gastrointestinal and colorectal disease;
- •Any major bowel surgery;
- •Medical history of liver and kidney disorders;
- •Regular use of laxative, anti-diarrhea and anti inflammatory medications.
结局指标
主要结局
Irritable Bowel Syndrome symptom severity score
时间窗: baseline and 8 weeks following therapy
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 . Scores of 75-175, 175-300, and 300-500 indicate mild, moderate, and severe cases.
次要结局
- Defecation frequency(baseline and 8 weeks following therapy)
- Stool consistency(baseline and 8 weeks following therapy)
- Quality of life score(baseline and 8 weeks following therapy)
研究者
Samira Rastgoo
Principal Investigator
Shahid Beheshti University of Medical Sciences
相似试验
已完成
不适用
Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in ChinaDiet ModificationIrritable Bowel SyndromeNCT03304041Sir Run Run Shaw Hospital108
已完成
不适用
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related SymptomsFODMAP DietFunctional DyspepsiaNCT06388330Universitaire Ziekenhuizen KU Leuven32
招募中
不适用
Low FODMAP Diet in FD (PDS)Functional Gastrointestinal DisordersNCT05832528Universitaire Ziekenhuizen KU Leuven30
尚未招募
不适用
the effect of gluten on clinical outcomes and quality of life in patients with irritable bowel syndromeIrritable bowel syndrome.Irritable bowel syndromeIRCT20100524004010N29Shahid Beheshti University of Medical Sciences50
已完成
不适用
The effect of glutamine on clinical outcomes, quality of life and intestinal permeability in patients with irritable bowel syndromeIrritable bowel syndromeIRCT20100524004010N28Shahid Beheshti University of Medical Sciences50