Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

Clinique Paris-Bercy8 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome Ulcerative Colitis

Interventions

OsteopathyOTHER

testing osteopathy Vs Treating osteopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinique Paris Bercy

Charenton-le-Pont, France