Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission

Conditions
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Irritable Bowel Syndrome, Ulcerative Colitis

Intervention / Treatment
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* Other: Osteopathy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treated group<br>The treated group will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. | Other: Osteopathy<br>* testing osteopathy Vs Treating osteopathy<br>|
| Sham Comparator: Untreated group<br>The untreated group will have 4 sessions of only testing osteopathy (M0, M1, M2, M3). | Other: Osteopathy<br>* testing osteopathy Vs Treating osteopathy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS) | index of severity of Irritable Bowel Syndrome symptoms | Month 1, Month 2, Month 3, Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBDQol : Inflammatory Bowel Disease Questionnaire | Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life | Month 1, Month 2, Month 3, Month 4 | 
| FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue | Validated fatigue score with question about quality of life 45/5000 if the score is high, the patient is tired | Month 1, Month 2, Month 3, Month 4 | 
| Evaluation of osteopathic dysfunctions | it will be interesting to see if patients with remission-prone RCH have similar osteopathic dysfunctions at the beginning of the study, and then if the management during the study influences or not these osteopathic dysfunctions. Osteopathic dysfunction is an alteration of the mobility, viscoelasticity or texture of somatic system components. It is accompanied or not by a painful sensibility. | Month 1, Month 2, Month 3, Month 4 | 
| Questionnaire for use of medication for Irritable Bowel Syndrome | if treatment modification, dose reduction or change in treatment | Month 1, Month 2, Month 3, Month 4 |