Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion recovery from diagnosis of IBS
研究概览
简要总结
Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm and screened for eligibility criteria. Participants follow a 12 month treatment program at Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. In parallel with the treatment program, the participant are clinically assessed for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months
详细描述
Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm. Eligible participants are screened for eligibility criteria at a baseline visit at the Karolinska Institutet. Patients providing written informed consent for participation are invited to Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. Before the first visit to the clinic, the participant fill out a longer questionnaire that is used for the planning of the participant's personal treatment program. At the first visit, the therapist goes through the responses together with the participant. Based on the participant's symptom profile, it is determined which tests are taken in the first step. Based on symptoms and test results, the therapist and participant come up with a treatment plan that can include several of the following components:
- Dietary changes
- Dietary supplements
- Measures to improve sleep / circadian rhythm
- Stress management
- Physical exercise
- Medicines, in exceptional cases.
The treatment plan is evaluated continuously by the participant and the therapist and adjusted accordingly.
The treatment involves a total of 9 visits to the Nordic Clinic during one year. The subsequent visits are planned by the therapist at the Nordic Clinic together with the participant.
In parallel with the treatment program, the participant makes return visits to Karolinska Institutet to collect follow-up data for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months after the start of treatment where participants are clinically assessed and fill out forms for the evaluation of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfills Rome IV criteria for IBS
- •Symptom burden on IBS-SSS >175
- •No symptom relief from standard medical treatment
- •No organic finding explaining the IBS symptoms (e.g. inflammation, parasites, thyroid disease, lactose intolerance, celiac disease, bile acid malabsorption)
排除标准
- •Pregnancy
- •Disease or life circumstances that prevent participation in the treatment program
结局指标
主要结局
Proportion recovery from diagnosis of IBS
时间窗: 12 months
Rome IV questionnaire is used to establish whether the participant fulfills the criteria for IBS at 12 months follow up
次要结局
- Change in BS severity symptom scale score(Baseline, 6, 12, 18 and 24 months)
- Change in total symptom burden(Baseline, 6, 12, 18 and 24 months)
- Change in work ability(Baseline, 6, 12, 18 and 24 months)
研究者
Greger Lindberg
Clinical Professor, MD
Karolinska Institutet