- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159311
Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission (OSTEOMIC)
Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteopathy has been shown to be effective in IBS patients in few studies and to improse 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bouchra Benkessou, SC
- Phone Number: 0033 764486016
- Email: b.benkessou@cliniques-bltparis.fr
Study Contact Backup
- Name: Maryan Cavicchi, MD, PhD
- Phone Number: 0033 0662346680
- Email: maryan.cavicchi@dbmail.com
Study Locations
-
-
-
Charenton Le Pont, France, 94220
- Recruiting
- Clinique Paris Bercy
-
Contact:
- BOUCHRA BENKESSOU, SC
- Phone Number: 0143967823
- Email: b.benkessou@clinique-bercy.fr
-
Contact:
- CLEO COURRENT
- Email: cleo.courrent@yahoo.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
testing osteopathy Vs Treating osteopathy
|
Sham Comparator: Untreated group
The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
|
testing osteopathy Vs Treating osteopathy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)
Time Frame: Month 1, Month 2, Month 3, Month 4
|
index of severity of Irritable Bowel Syndrome symptoms
|
Month 1, Month 2, Month 3, Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBDQol : Inflammatory Bowel Disease Questionnaire
Time Frame: 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
|
Month 1, Month 2, Month 3, Month 4
|
FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: 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 |
Month 1, Month 2, Month 3, Month 4
|
Evaluation of osteopathic dysfunctions
Time Frame: 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. |
Month 1, Month 2, Month 3, Month 4
|
Questionnaire for use of medication for Irritable Bowel Syndrome
Time Frame: Month 1, Month 2, Month 3, Month 4
|
if treatment modification, dose reduction or change in treatment
|
Month 1, Month 2, Month 3, Month 4
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maryan Cavicchi, MD, PhD, Clinique PARIS-BERCY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CParisBercy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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