Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

NCT04159311 | Terminated

• 1 other identifier: CParisBercy
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

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

  index of severity of Irritable Bowel Syndrome symptoms

  Month 1, Month 2, Month 3, Month 4

Secondary Outcomes (4)

• IBDQol : Inflammatory Bowel Disease Questionnaire

  Month 1, Month 2, Month 3, Month 4

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

  Month 1, Month 2, Month 3, Month 4

• Evaluation of osteopathic dysfunctions

  Month 1, Month 2, Month 3, Month 4

• Questionnaire for use of medication for Irritable Bowel Syndrome

  Month 1, Month 2, Month 3, Month 4

Study Arms (2)

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.

Other: Osteopathy

Untreated group

SHAM COMPARATOR

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

Other: Osteopathy

Interventions

Osteopathy OTHER

testing osteopathy Vs Treating osteopathy

Treated group; Untreated group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Patient \< 18 yoa
• Patient with colonic or ileal stenosis
• Patient diagnosed as undetermined colitis
• 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

Sponsors & Collaborators

• Clinique Paris-Bercy: lead

Study Sites (1)

Clinique Paris Bercy

Charenton-le-Pont, 94220, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Colitis, Ulcerative

Interventions

Osteopathic Physicians

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Maryan Cavicchi, MD, PhD

  Clinique Paris-Bercy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 12, 2019
• Study Start: November 18, 2019
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)