Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission (OSTEOMIC)

Clinique Paris-Bercy

Status: Terminated

Conditions: Irritable Bowel Syndrome; Ulcerative Colitis

Treatments: Other: Osteopathy

Study type: Interventional

Funder types: Other

Identifiers

NCT04159311

CParisBercy

Details and patient eligibility

About

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

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Treated group

Active Comparator group

Description:

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

Treatment:

Other: Osteopathy

Untreated group

Sham Comparator group

Description:

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

Treatment:

Other: Osteopathy