The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in constipation score
研究概览
简要总结
Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.
详细描述
This pilot study is an open label, pre-post interventional study to evaluate the use of ERME in the treatment of people with chronic constipation.
This study involves eligible participants that have a diagnosis constipation according to the Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.
Before intervention commences, participants will complete baseline breath samples and a 7 day stool diary to assess stool frequency and consistency.
Participants will then receive the ERME as instructed and continue to complete a bowel diary. Then at 4 weeks since starting the intervention, participants will provide another breath sample and complete another set of breath samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label, single arm
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has diagnosis of chronic constipation according to the KESS score.
- •Participant can communicate and understand English.
- •Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).
排除标准
- •Dependant use of opioid-based medications.
- •New use of prokinetic therapy during the study.
- •Use of antibiotics in the last 4 weeks.
- •Use of probiotics in the last 2 weeks.
- •Organic gastrointestinal disease, including inflammatory bowel disease (IBD), coeliac disease and diverticulitis.
- •Participant has known mechanical obstruction of the GI tract.
- •Participant has diabetes.
- •Participant has any hepatic disease.
- •Participant has any disease of the CNS.
- •Participant has had previous abdominal or colorectal surgery including appendectomy, cholecystectomy, and hysterectomy.
- •Participant has intake of ERME for 2 weeks before the study.
结局指标
主要结局
Change in constipation score
时间窗: 35 days
according to Knowels-Eccersley-Scott Symptom (KESS) score (likert scale of 0-3/4 with maximum score 39). Higher score = more severe
次要结局
- Change in breath methane levels(35 days)
- Change in flatulence(35 days)
- Change in bloating(35 days)
- Change in abdominal pain(35 days)
- Change in stool frequency(35 days)
研究者
Jordan Haworth
Clinical Physiologist
The Functional Gut Clinic