Mesotherapy Treatment of Irritable Bowel Syndrome

Inflammatory Bowel Diseases Clinical Trial

— MESOCOLO  

Official title:

Mesotherapy Treatment of Irritable Bowel Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06261320
• Other study ID #: 2023-506950-18-00
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 28, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Polyclinique de l'Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Polyclinique de l'Europe	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Polyclinique de l'Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Global satisfaction	4 questions with Likert scale of 5 items, to "not at all satisfied" to "very satisfied"	day 45
Secondary	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