Status:

UNKNOWN

OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Lead Sponsor:

Centre Hospitalier de Troyes

Collaborating Sponsors:

Institut National de la Santé Et de la Recherche Médicale, France

Conditions:

OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Eligibility:

All Genders

18+ years

Phase:

NA

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 foll...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2024

Estimated Enrollment :

404 Patients enrolled

Trial Details

Trial ID

NCT05230277

Start Date

March 1 2023

End Date

January 1 2024

Last Update

March 2 2023

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