Mesotherapy Treatment of Irritable Bowel Syndrome

Phase 2Active Not RecruitingNCT06261320

Polyclinique de l'Europe27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: day 30, day 45

Pain evaluation

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

Time frame: 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"

Time frame: 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).