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NCT Number: NCT06261320

Mesotherapy Treatment of Irritable Bowel Syndrome

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Polyclinique de l'Europe

Saint-Nazaire, 44600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate

Drug

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

Primary outcomes

  1. Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS)

    Time frame: 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.

Secondary outcomes

  1. Functional Digestive Disorders Quality of Life questionnaire (FDDQL)

    Time frame: day 30, day 45

    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.

  2. Pain evaluation

    Time frame: day 8, day 15, day 30, day 45

    Evaluation of pain with a scale from 0 (no pain) to 10 (worst pain imagined)

  3. Global satisfaction

    Time frame: day 45

    4 questions with Likert scale of 5 items, to "not at all satisfied" to "very satisfied"

  4. Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"

    Time frame: day 30, day 45

    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).

Sponsors and collaborators

Lead sponsor

Polyclinique de l'Europe

Other

Registry information

Acronym: MESOCOLO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 15, 2024
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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