Clinical trial NCT04159311: Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission
Official title: Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irritable Bowel Syndrome
Ulcerative Colitis
Lead sponsor: Clinique Paris-Bercy
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)
timeFrame: Month 1, Month 2, Month 3, Month 4
Secondary outcomes:
measure: IBDQol : Inflammatory Bowel Disease Questionnaire
timeFrame: Month 1, Month 2, Month 3, Month 4
measure: FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Month 1, Month 2, Month 3, Month 4
measure: Evaluation of osteopathic dysfunctions
timeFrame: Month 1, Month 2, Month 3, Month 4
measure: Questionnaire for use of medication for Irritable Bowel Syndrome
timeFrame: Month 1, Month 2, Month 3, Month 4
Other outcomes:
Locations:
city: Charenton Le Pont
country: France
facility: Clinique Paris Bercy
Study officials:
affiliation: Clinique Paris-Bercy
name: Maryan Cavicchi, MD, PhD
role: STUDY_DIRECTOR
References: