ACTRN12624000551594进行中（未招募）Unknown
Proof of concept, feasibility and acceptability of an online FODMAP intervention for adults with irritable bowel syndrome.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults aged 18 years or older with self-reported IBS which meets ROME IV criteria. Potential participants must be symptomatic at time of recruitment as indicated by a symptom severity score >75 measured using the IBS-SSS (IBS Symptom Severity Score)
排除标准
- •Presence or known history of other GI diseases i.e. coeliac disease or inflammatory bowel disease) or history of major GI surgery (except appendectomy or haemorrhoidectomy).
- •Presence of major comorbidities that could explain current gastrointestinal symptoms i.e. severe diabetic, cardiac, liver, neurological, neuropathy disease.
- •Alarm symptoms (e.g. blood in stool, rapid weight loss, nocturnal symptoms, recent change in bowel habits if >50 years) shown to predict presence of organic diseases.
- •Less than 2 years of IBS symptoms regardless of when diagnosis given
- •History or current diagnosis of anorexia nervosa, binge eating disorder or bulimia nervosa). Participants with avoidant/restrictive food intake disorder (ARFID) or milder forms of disordered eating may be included.
- •History or current diagnosis of psychotic disorder or bipolar disorder; current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation.
- •Body Mass Index (BMI) < 18.5kg/m2
- •Pregnant or lactating or plans to become pregnant during study duration
- •Currently on a restriction/elimination diet for gastrointestinal symptoms (e.g. low FODMAP diet, gluten free diet) or have undertaken the 3-phase low FODMAP diet delivered by a dietitian within the last two years. Those following a lactose free diet will be eligible if they agree to keep intake consistent unless advised to reduce further.
- •Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure)
- •Currently undertaking brain-gut behaviour therapy (e.g. gut-directed hypnotherapy; gut-directed psychotherapy; mindfulness-based stress reduction; mindfulness-based cognitive therapy). Participants engaged in regular stress reduction activities such as breathing exercises, psychology counselling, mindfulness, and/or physical activity will be encouraged to continue with these activities during the 12-week intervention program.
- •Commenced or change in dose of IBS medications (e.g. antidepressants) in the three months preceding study commencement.
- •Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrhoeals and laxatives) in the month preceding study commencement. Supplements such as probiotics, prebiotics, fibre supplements and digestive enzymes will be allowed, provided that participants have been on a stable dose for at least 1 month before inclusion.
- •Not willing to change current diet or dietary supplement intake (e.g. fibre supplements)
- •No access to internet or computer
- •Insufficient language or computer skills to complete a text based online treatment.
- •Inability to provide informed consent
研究者
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