A Pilot Study of a Multi-Strain Liquid Probiotic in Individuals Self-reporting Constipation in the General Population.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Assessment of Constipation-Symptoms (PAC-SYM)
研究概览
简要总结
Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies.
Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment.
The multistrain live bacterial food product (probiotic) being tested contains billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc.
This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- •Participant has Cleveland Clinic constipation score (CCCS) of 9-16 at screening call
- •Participant is willing to discontinue all other therapies for constipation and undergo washout where applicable.
- •Participant is a male or non-pregnant female and is 18-70 years of age
- •If WOCBP participant is willing to adhere to one of the following methods of contraception:
- •i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) vi) Sexual abstinence (if it is in line with participants' preferred and usual lifestyle).
- •or has had a: v) Hysterectomy or has a: vi) Vasectomised partner
- •Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- •Participant has capacity to understand written English.
- •Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
- •Participant agrees to follow all pre-test preparation for the ATMO capsule transit study.
排除标准
- •Women who are pregnant and/or breastfeeding.
- •Participants who are planning to significantly change their diet (e.g. weight loss program, becoming vegetarian) during the study period.
- •Participant has had diarrhoea within 7 weeks of screening period.
- •Prior abdominal surgery involving resection of the small or large bowel.
- •Prior bariatric surgery involving resection of the stomach or by-pass procedures.
- •Type 1 diabetes mellitus.
- •Known organic or structural GI disease including:
- •Coeliac disease
- •Inflammatory bowel disease
- •Diverticulitis
- •Small bowel strictures
- •Irritable bowel syndrome where the predominant symptom is pain (assessed via screening questions).
- •Oropharyngeal dysphagia or difficulty swallowing capsules.
- •Any other medical condition that the investigator deems may confound results or affect participants' safety in the study.
- •Any use of prohibited medication that the participant cannot complete appropriate washout for.
- •Insufficient knowledge of English to complete the daily bowel diary.
- •Allergy to any component of the supplement, motility bar, lactulose or Zoe blue cookie.
- •Participant is involved in this study as an investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
- •Previous use of the probiotic Symprove.
结局指标
主要结局
Patient Assessment of Constipation-Symptoms (PAC-SYM)
时间窗: Pre-post comparison (28 days)
Number of participants with clinically meaningful change in PAC-SYM score (reduction of \>0.6 or \>0.75 points). The PAC-SYM questionnaire is a 12 item validated patient-reported measure of severity of constipation symptoms during the past two weeks.
次要结局
- Patient Assessment of Constipation - Quality of Life (PAC-QoL)(Pre-Post comparison (28 days))
- Participant Compliance(Pre-Post comparison (28 days))
- Whole Gut Transit Time (ATMO)(Pre-Post comparison (28 days))
- Whole Gut Transit Time (Blue-dye)(Pre-Post comparison (28 days))
- Small Bowel Transit Time (ATMO)(Pre-Post comparison (28 days))
- Large Bowel Transit Time (ATMO)(Pre-Post comparison (28 days))
- Gastrointestinal Symptom Rating Scale (GSRS)(Pre-Post comparison (28 days))
- Stool form comparison(Pre-Post comparison (days 1-14 compared to days 29-42))
- Stool frequency comparison(Pre-Post comparison (days 1-14 compared to days 29-42))
- Hydrogen and methane production(Pre-Post comparison (days 1-14 compared to days 15-42))
- Global PAC-SYM(Pre-Post comparison (28 days))
- Inidividual PAC-SYM(Pre-Post comparison (28 days))
- Straining(Pre-Post comparison (days 1-14 compared to days 15-42))
- Sense of complete evacuation(Pre-Post comparison (days 1-14 compared to days 15-42))
- Time taken for evacuation(Pre-Post comparison (days 1-14 compared to days 15-42))
- Rescue Medication(Pre-Post comparison (days 1-14 compared to days 15-42))
研究者
Dr Anthony Hobson
Clinical Director and Senior Clinical GI Scientist
The Functional Gut Clinic