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

Primary Purpose

Irritable Bowel Syndrome, Ulcerative Colitis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Osteopathy

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinique Paris BercyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treated group

Untreated group

Arm 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.

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

Outcomes

Primary Outcome Measures

Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)

index of severity of Irritable Bowel Syndrome symptoms

Secondary Outcome Measures

IBDQol : Inflammatory Bowel Disease Questionnaire

Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life

FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue

Validated fatigue score with question about quality of life 45/5000 if the score is high, the patient is tired

Evaluation of osteopathic dysfunctions

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.

Questionnaire for use of medication for Irritable Bowel Syndrome

if treatment modification, dose reduction or change in treatment

Full Information

NCT ID

NCT04159311

First Posted

October 17, 2019

Last Updated

December 30, 2019

Sponsor

Clinique Paris-Bercy

1. Study Identification

Unique Protocol Identification Number

NCT04159311

Brief Title

Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

Acronym

OSTEOMIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 14, 2019 (Actual)

Primary Completion Date

November 2, 2021 (Anticipated)

Study Completion Date

November 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinique Paris-Bercy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Ulcerative Colitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated group

Arm Type

Active Comparator

Arm 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.

Arm Title

Untreated group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Osteopathy

Intervention Description

testing osteopathy Vs Treating osteopathy

Primary Outcome Measure Information:

Title

Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)

Description

index of severity of Irritable Bowel Syndrome symptoms

Time Frame

Month 1, Month 2, Month 3, Month 4

Secondary Outcome Measure Information:

Title

IBDQol : Inflammatory Bowel Disease Questionnaire

Description

Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life

Time Frame

Month 1, Month 2, Month 3, Month 4

Title

FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue

Description

Validated fatigue score with question about quality of life 45/5000 if the score is high, the patient is tired

Time Frame

Month 1, Month 2, Month 3, Month 4

Title

Evaluation of osteopathic dysfunctions

Description

Time Frame

Month 1, Month 2, Month 3, Month 4

Title

Questionnaire for use of medication for Irritable Bowel Syndrome

Description

if treatment modification, dose reduction or change in treatment

Time Frame

Month 1, Month 2, Month 3, Month 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bouchra Benkessou, SC

Phone

0033 764486016

b.benkessou@cliniques-bltparis.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Maryan Cavicchi, MD, PhD

Phone

0033 0662346680

maryan.cavicchi@dbmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maryan Cavicchi, MD, PhD

Organizational Affiliation

Clinique Paris-Bercy

Official's Role

Study Director

Facility Information:

Facility Name

Clinique Paris Bercy

City

Charenton Le Pont

ZIP/Postal Code

94220

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BOUCHRA BENKESSOU, SC

Phone

0143967823

b.benkessou@clinique-bercy.fr

First Name & Middle Initial & Last Name & Degree

CLEO COURRENT

cleo.courrent@yahoo.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

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