Mesotherapy Treatment of Irritable Bowel Syndrome

NCT ID: NCT06261320

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2027-01-31

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

Intervention Type: DRUG

4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.

Interventions

Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polyclinique de l'Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Polyclinique de l'Europe

Saint-Nazaire, , France

Countries

France

Other Identifiers

2023-506950-18-00

Identifier Type: -

Identifier Source: org_study_id