Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

Not Applicable

Terminated

• Conditions: Ulcerative Colitis; Irritable Bowel Syndrome
• Interventions: Other: Osteopathy

• Registration Number: NCT04159311
• Lead Sponsor: Clinique Paris-Bercy

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2019-11-18
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Untreated group	Osteopathy	The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
Treated group	Osteopathy	The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3.

Primary Outcome Measures

Name	Time	Method
Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)	Month 1, Month 2, Month 3, Month 4	index of severity of Irritable Bowel Syndrome symptoms

Secondary Outcome Measures

Name	Time	Method
IBDQol : Inflammatory Bowel Disease Questionnaire	Month 1, Month 2, Month 3, Month 4	Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life
Questionnaire for use of medication for Irritable Bowel Syndrome	Month 1, Month 2, Month 3, Month 4	if treatment modification, dose reduction or change in treatment
FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue	Month 1, Month 2, Month 3, Month 4	Validated fatigue score with question about quality of life 45/5000; if the score is high, the patient is tired
Evaluation of osteopathic dysfunctions	Month 1, Month 2, Month 3, Month 4	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.

Trial Locations

Locations (1)

Clinique Paris Bercy; 🇫🇷 Charenton Le Pont, France