Personalised Multidisciplinary Multimodal Treatment in IBS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- IBS symptom severity score
研究概览
简要总结
This is a 12-month longitudinal intervention study in adults (18-65 years) with moderate-severe IBS (IBS-SSS ≥175) evaluating a personalized, patient-centered multidisciplinary treatment delivered in a Swedish tertiary care setting. The program includes an internet-based IBS school followed by four evidence-based modules (physician-led medical management/education, dietician-led dietary intervention, psychologist-led IBS-focused behavioral therapy, and physiotherapy) delivered in a sequence chosen by the participant, with symptom evaluation after each module. Outcomes are assessed before and after treatment, with the primary endpoint defined as treatment response (IBS-SSS reduction ≥50 points), and secondary endpoints covering symptom/psychological measures, visceral sensitivity and biological stress plus gut biomarkers, and multimodal brain imaging (structural MRI, rs-fMRI, task fMRI, and insula MRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS diagnosis confirmed according to the Rome IV criteria
- •Moderate-to-severe symptoms based on the IBS Symptom Severity Score (IBS-SSS)
- •Age 18-65 years
- •Written informed consent.
排除标准
- •Contraindications to MRI, e.g., claustrophobia, pregnancy, or metallic implants.
- •History of major gastrointestinal surgery, e.g., appendectomy.
- •Severe psychiatric illness, such as bipolar disorder or schizophrenia.
- •Insufficient Swedish language knowledge to complete the questionnaires
研究组 & 干预措施
Multidisciplinary multimodal intervention (IBS)
Single-arm intervention: all participants are assigned to a multimodal, multidisciplinary IBS treatment program delivered by a multidisciplinary team. No control group was included due to the nature of the study.
干预措施: Physician-module (Other)
Multidisciplinary multimodal intervention (IBS)
Single-arm intervention: all participants are assigned to a multimodal, multidisciplinary IBS treatment program delivered by a multidisciplinary team. No control group was included due to the nature of the study.
干预措施: Dietician module (Other)
Multidisciplinary multimodal intervention (IBS)
Single-arm intervention: all participants are assigned to a multimodal, multidisciplinary IBS treatment program delivered by a multidisciplinary team. No control group was included due to the nature of the study.
干预措施: Psychologist module (Other)
Multidisciplinary multimodal intervention (IBS)
Single-arm intervention: all participants are assigned to a multimodal, multidisciplinary IBS treatment program delivered by a multidisciplinary team. No control group was included due to the nature of the study.
干预措施: Physiotherapy module (Other)
结局指标
主要结局
IBS symptom severity score
时间窗: From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.
The primary outcome was treatment response, defined as a reduction of ≥50 points in the IBS Symptom Severity Score (IBS-SSS). Participants achieving this reduction were classified as responders.
次要结局
- Changes in Gastrointestinal symptom severity(Baseline, 3, 6, 9, and 12 months)
- Psychological symptom burden(At the baseline, 3 months, 6 months, 9 months and end of intervention (12 months))
- Visceral sensitivity index (VSI)(Baseline, 3, 6, 9, and 12 months)
- Changes in Gut-brain axis physiology(Baseline and 12 months.)
- Brain imaging outcomes - Brain Structure(At the baseline and after 12 months.)
- Brain imaging outcomes - Brain neurochemistry(Baseline and 12 months.)
- Brain imaging outcomes - Brain function (BOLD signal activity)(Baseline and 12 months.)
- Serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations(Baseline and 12 months.)
研究者
Susanna Walter
MD, PhD and Adjunct Professor
Ostergotland County Council, Sweden