Mesotherapy Treatment of Irritable Bowel Syndrome (MESOCOLO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Saint-Nazaire, France, 44600
    • Polyclinique de l'Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate; 4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS)	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.	day 8, day 15, day 30, day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Digestive Disorders Quality of Life questionnaire (FDDQL)	43 items with 8 subscales : daily activity, anxiety, nutrition, sleep, discomfort, health perception, adaptation and impact of stress Global score is between 0 and 100.	day 30, day 45
Pain evaluation	Evaluation of pain with a scale from 0 (no pain) to 10 (worst pain imagined)	day 8, day 15, day 30, day 45
Global satisfaction	4 questions with Likert scale of 5 items, to "not at all satisfied" to "very satisfied"	day 45
Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"	14 items with 7 about depression and 7 about anxiety. Each item is noted with a Likert scale of 4 points, from 0 (no symptoms) to 3 (strong symptoms).	day 30, day 45

Collaborators and Investigators

• Sponsor: Polyclinique de l'Europe

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: inflammatory bowel disease; mesotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colonic Diseases, Functional; Irritable Bowel Syndrome; Intestinal Diseases; Inflammatory Bowel Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Adrenergic Agents; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Adrenergic Uptake Inhibitors; Antidepressive Agents, Tricyclic; Amitriptyline; Trimecaine
• Other Study ID Numbers: 2023-506950-18-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No