Clinical trial NCT05230277: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS
Official title: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS
Lead sponsor: Centre Hospitalier de Troyes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-02-08
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The effectiveness (response to treatment) at 1-month follow-up:
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: