Efficacy and Safety of Dietary Supplementation of Diamine Oxidase (DAO) to Improve Symptoms in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- IBS-SSS
研究概览
简要总结
This project is a single center, randomized, controlled clinical trial evaluating the effects of DAO enzyme dietary supplement on symptoms of irritable bowel syndrome.
These participants are randomized to either a 4-week group with DAO enzyme dietary supplement or placebo. The participants are required to fill out IBS-SSS and IBS-QOL questionnaires and record their IBS symptom improvement, IBS treatment drug use, compliance and adverse reactions every evening. At the same time, the patients' diet is continuously recorded for 3 days by 24-hour diet review method in Visit 0, Visit 1 and Visit 2, respectively, to inform the patients to avoid large fluctuations in diet structure. On days 0, 14 and 28, the subjects are asked to visit the hospital offline. The staff check with the subjects in detail according to the scale and questionnaire contents, and review the general situation and questionnaire in the previous 2 weeks. On the 7th and 21st day, the staff contact the subjects online to provide guidance and remind the subjects to fill in the scale and questionnaire. In addition, oral mucosal samples, urine and feces will be collected for identifying mutations in the genetic DAO enzyme coding gene, histamine detection and 16sRNA sequencing, respectively.
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
- Triple (Participant, 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
- •Age 18-65 years old;
- •Diagnosed with IBS according to Rome IV diagnostic criteria; Recurrent abdominal pain occurred on an average of at least 1 day per week in the past 3 months and was associated with two or more of the following criteria: i. Related to defecation; ii. Associated with changes in bowel frequency; iii. Correlated with fecal morphological changes. The symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months.
- •Voluntarily participate in the experiment and sign the informed consent.
排除标准
- •Patients with endoscopy examinations which suggest chronic intestinal diseases other than IBS, such as inflammatory bowel disease, celiac disease, gastric and duodenal ulcers, parasitic or bacterial intestinal infections;
- •Pregnant and lactating women;
- •Patients suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease, tumor;
- •Alcoholism.
研究组 & 干预措施
DAO supplement group
One tablet of the supplementary study product was taken orally before morning, lunch and dinner every day, and each tablet contained 4.2mg of dehydrated pea seedling powder.
干预措施: DAO supplement (Drug)
Placebo group
Placebo was orally supplemented with one tablet each day before morning, lunch and dinner, and placebo did not contain dehydrated pea seedling powder 4.2mg.
干预措施: Placebo (Drug)
结局指标
主要结局
IBS-SSS
时间窗: 4 weeks of study medication administration
The effects of DAO enzyme dietary supplement from dehydrated pea seedling powder on IBS symptoms were evaluated by the Severity Scale of irritable bowel Syndrome (IBS-SSS) and the changes of several independent symptoms.
次要结局
- Improvement of symptoms listed in the Rome IV diagnostic criteria for IBS(4 weeks of study medication administration)
- IBS-QOL(4 weeks of study medication administration)
研究者
Zhenyu Zhang
Chief physician
Nanjing First Hospital, Nanjing Medical University