Mesotherapy Treatment of Irritable Bowel Syndrome (MESOCOLO)

Polyclinique de l'Europe

Status and phase: Active, not recruiting; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

Study type: Interventional

Funder types: Other

Identifiers

NCT06261320

2023-506950-18-00

Details and patient eligibility

About

Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.

Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.

Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology,
• Francis score >75/500, i.e. minimal, moderate or severe severity,
• Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms)
• Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment

Exclusion criteria

• Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology
• Recent Post Traumatic Stress Syndrome (<1 year),
• Fibromyalgia syndrome,
• Known allergy to medications used in mesotherapy treatment,
• Pregnant or breastfeeding woman

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate