Irritable Bowel SyndromeOSTEOMICNCT04159311
Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission
A study testing Osteopathy in people with Irritable Bowel Syndrome and Ulcerative Colitis, run by Clinique Paris-Bercy at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Irritable Bowel Syndrome, Ulcerative Colitis
- What is being tested?
- Osteopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2019to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Irritable Bowel Syndrome, Ulcerative Colitis
- Being tested
- Osteopathy
- Medical subject headings
- Irritable Bowel Syndrome, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathyOther
testing osteopathy Vs Treating osteopathy
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Active comparator | The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. Receives: Other: Osteopathy |
| Untreated group | Sham comparator | The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3). Receives: Other: Osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS)
index of severity of Irritable Bowel Syndrome symptoms
Measured: Month 1, Month 2, Month 3, Month 4
Secondary outcomes (4)
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
Measured: Month 1, Month 2, Month 3, Month 4
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
Measured: Month 1, Month 2, Month 3, Month 4
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.
Measured: Month 1, Month 2, Month 3, Month 4
Questionnaire for use of medication for Irritable Bowel Syndrome
if treatment modification, dose reduction or change in treatment
Measured: Month 1, Month 2, Month 3, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start18 Nov 2019
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Why it stopped: The study encountered difficulties in including patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Paris-Bercy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryan Cavicchi, MD, PhD, Study director, Clinique Paris-Bercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159311
- Sponsor's protocol ID
- CParisBercy
- Acronym
- OSTEOMIC
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission
- ClinicalTrials.gov ID
- NCT04159311
- Acronym / sponsor ID
- OSTEOMIC / CParisBercy
- Conditions
- Irritable Bowel Syndrome, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study encountered difficulties in including patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clinique Paris-BercyUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Active comparator | Other: OsteopathyThe "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. |
| Untreated group | Sham comparator | Other: OsteopathyThe "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathytesting osteopathy Vs Treating osteopathy | Other | Treated group, Untreated group |
Primary outcome
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
4 secondary outcomes
IBDQol : Inflammatory Bowel Disease Questionnaire
Time frame: 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
Evaluation of osteopathic dysfunctions
Time frame: 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
Results and safety
The study was stopped early (reason given: The study encountered difficulties in including patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryan Cavicchi, MD, PhD study director
Clinique Paris-Bercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathy in people with Irritable Bowel Syndrome and Ulcerative Colitis, run by Clinique Paris-Bercy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study encountered difficulties in including patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS) (time frame: Month 1, Month 2, Month 3, Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.