Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

NCT ID: NCT04159311

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-11-02

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

Conditions

Irritable Bowel Syndrome; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Treated group

The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3.

Group Type: ACTIVE_COMPARATOR

Osteopathy

Intervention Type: OTHER

testing osteopathy Vs Treating osteopathy

Untreated group

The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).

Group Type: SHAM_COMPARATOR

Osteopathy

Intervention Type: OTHER

testing osteopathy Vs Treating osteopathy

Interventions

Osteopathy

testing osteopathy Vs Treating osteopathy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Paris-Bercy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryan Cavicchi, MD, PhD

Role: STUDY_DIRECTOR

Clinique Paris-Bercy

Locations

Clinique Paris Bercy

Charenton-le-Pont, , France

Countries

France

Other Identifiers

CParisBercy

Identifier Type: -

Identifier Source: org_study_id