Clinical trial NCT06261320: Mesotherapy Treatment of Irritable Bowel Syndrome
Official title: Mesotherapy Treatment of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Keywords: mesotherapy
inflammatory bowel disease
Lead sponsor: Polyclinique de l'Europe
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS)
timeFrame: day 8, day 15, day 30, day 45
Secondary outcomes:
measure: Functional Digestive Disorders Quality of Life questionnaire (FDDQL)
timeFrame: day 30, day 45
measure: Pain evaluation
timeFrame: day 8, day 15, day 30, day 45
measure: Global satisfaction
timeFrame: day 45
measure: Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"
timeFrame: day 30, day 45
Other outcomes:
Locations:
city: Saint-Nazaire
country: France
facility: Polyclinique de l'Europe
Study officials:
References: