Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)
研究概览
简要总结
Type : interventional, randomized single blind study Aim : to evaluate 3 sessions of osteopathy on IBS-like symptoms associated with ulcerative colitis in remission Number of patients : 50 (randomization 1:1) Duration of the inclusion period : 2 years Primary end-point : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months
详细描述
Osteopathy has been shown to be effective in IBS patients in few studies and to improve IBS-like symptoms in a short series of Crohn patients. IBS-like symptoms are frequent in patients with ulcerative colitis in remission (about 20 %).
The aim of this interventional, randomized single blind study is to evaluate the impact of 3 sessions of osteopathy on Irritable Bowel Syndrome symptoms in 50 patients (randomisation 1:1) with ulcerative colitis in remission (defined by fecal calprotectin < 200 µg/g).
The two group of patients will have 4 sessions of osteopathy (M0, M1, M2, M3). The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
Primary end-points : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months (M3) Secondary end-points : Inflammatory Bowel Disease Questionnaire ol, Functional Assessment of Chronic Illness Therapy-Fatigue at M3, evaluation of osteopathic dysfunctions between M0 and M3, questionnaire for use of medication for IBS between M0 and M3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age between 18 and 90
- •Patient with ulcerative colitis (whatever the Montreal grade, E1, E2 or E3) In clinical remission for at least 3 months and with fecal calprotectin < 200 µg/g
- •No modification of Ulcerative Colitis treatment for at least 3 months
- •Patient with IBS-liked symptoms defined as in Rome IV classification for Irritable Bowel Syndrome
- •Patient with Irritable Bowel Syndrome Severity Scoring System > 75 at screening
- •Patient affiliated to the French Social Security regimen
排除标准
- •Patient refusal
- •Patient < 18 yoa
- •Patient with colonic or ileal stenosis
- •Patient diagnosed as undetermined colitis
- •Patient not in remission for Ulcerative Colitis as defined by an endoscopic Mayo score > 1 within the 3 months preceding the inclusion and/or fecal calprotectin > 200 µg/g at inclusion
- •Osteopathy session(s) within 1 month before inclusion
- •Patient with Inflammatory rheumatic disorders (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis)
- •Patient with Irritable Bowel Syndrome Severity Scoring System <75 at screening
- •Patient above 18 yoa with law guardianship
结局指标
主要结局
Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)
时间窗: Month 1, Month 2, Month 3, Month 4
index of severity of Irritable Bowel Syndrome symptoms
次要结局
- IBDQol : Inflammatory Bowel Disease Questionnaire(Month 1, Month 2, Month 3, Month 4)
- FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue(Month 1, Month 2, Month 3, Month 4)
- Evaluation of osteopathic dysfunctions(Month 1, Month 2, Month 3, Month 4)
- Questionnaire for use of medication for Irritable Bowel Syndrome(Month 1, Month 2, Month 3, Month 4)