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Active, not recruiting Phase 2

Mesotherapy Treatment of Irritable Bowel Syndrome

NCT06261320 · tracked via the Priya Life Science France tracker
Sponsor
Polyclinique de l'Europe
Phase
Phase 2
Started
2024-02-28
Last updated
2025-05-31

Condition(s) studied

Inflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) — day 8, day 15, day 30, day 45
    Includes 5 items regarding pain (intensity and number of days), abdominal distention, satisfaction of bowel habit, and interference of daily life of the last 10 d on a 10-point scale. Gives a score between 0 and 500, and groups of severity can be made: mild (≤175), moderate (175-300), and severe (≥300) IBS.

Trial sites (1)

FacilityCityRegionStatus
Polyclinique de l'Europe Saint-Nazaire France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06261320 on ClinicalTrials.gov ↗ ← All trials in France