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

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ClinicalTrials.gov Identifier: NCT04159311
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Ulcerative Colitis Other: Osteopathy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : November 2, 2021
Estimated Study Completion Date : November 2, 2021

Resource links provided by the National Library of Medicine


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.
Other: Osteopathy
testing osteopathy Vs Treating osteopathy

Sham Comparator: Untreated group
The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
Other: Osteopathy
testing osteopathy Vs Treating osteopathy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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.


  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159311


Contacts
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Contact: Bouchra Benkessou, SC 0033 764486016 b.benkessou@cliniques-bltparis.fr
Contact: Maryan Cavicchi, MD, PhD 0033 0662346680 maryan.cavicchi@dbmail.com

Locations
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France
Clinique Paris Bercy Recruiting
Charenton Le Pont, France, 94220
Contact: BOUCHRA BENKESSOU, SC    0143967823    b.benkessou@clinique-bercy.fr   
Contact: CLEO COURRENT       cleo.courrent@yahoo.fr   
Sponsors and Collaborators
Clinique Paris-Bercy
Investigators
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Study Director: Maryan Cavicchi, MD, PhD Clinique Paris-Bercy
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Responsible Party: Clinique Paris-Bercy
ClinicalTrials.gov Identifier: NCT04159311    
Other Study ID Numbers: CParisBercy
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Irritable Bowel Syndrome
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Colonic Diseases, Functional