OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Not Applicable

Not yet recruiting

• Conditions: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

• Registration Number: NCT05230277
• Lead Sponsor: Centre Hospitalier de Troyes

Brief Summary

Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.

Detailed Description

a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: inclusion and baseline assessment (Day-1; Initial visit V0), Day 8, Day 15 and follow-up (1 month and 3 months), treatments (Day 0, Day 8, Day 15). Primary endpoint: Effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 404

Inclusion Criteria

• Male or female patients ≥ 18 ans
• IBS patients (defined according to the Rome IV Criteria)
• Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
• Negative colonoscopy within the last 5 years.
• Psychologically fit to provide signed informed consent.
• Agreed to undergo the procedures associated with the study
• Medical insurance

Exclusion Criteria

• Have not received any osteopathic treatment in the last 12 months
• Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
• Pregnancy
• Planned or expected elective surgery during the study
• Dietary and lifestyle changes in the previous month.
• Use of prohibited concomitant medications in the previous month.
• Inability to understand or cooperate during the study.
• No current participation in a biomedical research trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The effectiveness (response to treatment) at 1-month follow-up:	1 month	It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.

Secondary Outcome Measures

Name	Time	Method
Effectiveness at 3 months (response to treatment based on the IBS-SSS) and changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 months.	3 months	It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.; Changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 monthsThe IBS-QOL is a self-report measure of quality of life specific to irritable bowel syndrome (IBS) often used to assess the impact of IBS and its treatment.