A Phase 2 interventional study of Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate in Inflammatory Bowel Diseases, sponsored by Polyclinique de l'Europe. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Polyclinique de l'Europe · Phase 2, Interventional, and Treatment
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Polyclinique de l'Europe is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate
4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.
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
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).
Time frame: day 30, day 45
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Polyclinique de l'Europe