STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Eligibility rate
研究概览
简要总结
To investigate the feasibility of proton pump inhibitor (PPI) withdrawal in inflammatory bowel disease (IBD); the data collected will provide valuable information to inform a future multi-centre randomised controlled trial.
Evidence suggests that patients with IBD taking PPIs respond less well to medication and require hospital treatment more frequently than patients not taking PPIs. This may be due to changes in the gut microbiota associated with PPI use.
A future definitive trial is planned to investigate clinical outcomes in patients who stop PPIs compared with those who continue PPIs, in order to determine the safety implications of PPI use in IBD. However, several uncertainties remain which require investigation before such a trial can be undertaken. It is currently unknown how many patients with IBD take PPIs, how many can successfully stop taking PPIs, how many would be willing to stop treatment, and how many would remain off treatment long term. In some cases, withdrawal of PPIs may result in a short-term increase in acid reflux symptoms. The willingness of patients to participate in such a study is also unknown. This study will be conducted in GP practices, a setting in which IBD trials have not previously been undertaken.
The study will recruit 80 participants with IBD aged 16 years and over who have been taking PPIs regularly for more than six months. Half of participants will be randomised to discontinue PPI therapy. Participants will be followed up for 12 months. The study will provide information regarding recruitment rates within GP practices, optimal methods for PPI withdrawal, and whether stopping PPIs affects IBD outcomes.
详细描述
PURPOSE
The purpose of this study is to explore the feasibility of proton pump inhibitor (PPI) withdrawal in patients with IBD in order to inform the running of a larger scale study.
PRIMARY OBJECTIVES
To understand the feasibility of PPI withdrawal in order to inform a future definitive multi-centre randomised controlled trial by investigating:
How many patients are eligible for this study. What the recruitment rate is - baseline variables predicting non-recruitment from screened patients will be investigated.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16 years or older.
- •An IBD diagnosis as defined through SNOMED codes in primary care databases [Appendix 5]
- •Taking a PPI regularly for >6 months prior to enrolment
- •Patient-confirmed compliance with PPI therapy (>75% of prescribed doses)
- •Able to give full, independent valid Informed consent
- •Stable disease as defined by no change in medication or IBD-related surgery for the last 3 months.
排除标准
- •Unable to participate fully in all aspects of the clinical trial.
- •Barrett's oesophagus
- •Peptic disease at a recent upper GI endoscopy
- •Zollinger-Ellison Syndrome
- •Eosinophilic oesophagitis
- •Chronic NSAID usage
- •Pulmonary fibrosis.
- •Declined consent to data sharing
- •History of dementia
- •Terminal illness
- •Present malignancy
- •Active history of mental illness
- •In a care home
- •Alcohol misuse
- •Illicit drug misuse
结局指标
主要结局
Eligibility rate
时间窗: 12 months
The proportion of screened patients meeting the study eligibility criteria.
Recruitment rate
时间窗: 12 months
The proportion of eligible patients who consent to participate in the study. Baseline variables associated with non-recruitment among screened patients will also be explored.
Adherence to allocated intervention
时间窗: 12 months
The proportion of participants adhering to their allocated treatment strategy (PPI withdrawal or PPI continuation). Factors associated with non-adherence will be explored.
Participant retention rate
时间窗: 12 months
The proportion of recruited participants who complete study follow-up.
次要结局
- Effect of PPI withdrawal on inflammatory bowel disease activity in participants with ulcerative colitis(12 months)
- Effect of PPI withdrawal on inflammatory bowel disease activity in participants with Crohn's disease(12 months)
- Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)(12 months)
- Dyspepsia symptoms measured using the Glasgow Dyspepsia Severity Score (GDSS)(12 months)