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

December 30, 2019 updated by: Clinique Paris-Bercy

Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission

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

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Maryan Cavicchi, MD, PhD, Clinique PARIS-BERCY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Anticipated)

November 2, 2021

Study Completion (Anticipated)

November 2, 2021

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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