Mesotherapy Treatment of Irritable Bowel Syndrome

NCT06261320 | Active Not Recruiting Phase 2

• 1 other identifier: 2023-506950-18-00
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

mesotherapy; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Digestive Disorders Quality of Life questionnaire (FDDQL)

  day 30, day 45

• Pain evaluation

  day 8, day 15, day 30, day 45

• Global satisfaction

  day 45

• Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"

  day 30, day 45

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Interventions

Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polyclinique de l'Europe: lead

Study Sites (1)

Polyclinique de l'Europe

Saint-Nazaire, 44600, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Mesotherapy; Trimecaine; thiocolchicoside; Amitriptyline; Pyrrolidonecarboxylic Acid

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Imino Acids; Amino Acids, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)