Clinical Trials Directory

Trials / Terminated

TerminatedNCT04159311

Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Clinique Paris-Bercy · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHEROsteopathytesting osteopathy Vs Treating osteopathy

Timeline

Start date
2019-11-18
Primary completion
2021-11-02
Completion
2021-11-02
First posted
2019-11-12
Last updated
2023-11-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04159311. Inclusion in this directory is not an endorsement.