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
| Type | Name | Description |
|---|---|---|
| OTHER | Osteopathy | testing 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.