Inflammatory Bowel DiseasesPhase 2MESOCOLONCT06261320
Mesotherapy Treatment of Irritable Bowel Syndrome
A Phase 2 study testing Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate in people with Inflammatory Bowel Diseases, run by Polyclinique de l'Europe at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate
- Keywords
- mesotherapy, inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolateDrug
4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 8, day 15, day 30, day 45
Secondary outcomes (4)
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.
Measured: day 30, day 45
Pain evaluation
Evaluation of pain with a scale from 0 (no pain) to 10 (worst pain imagined)
Measured: 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"
Measured: 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).
Measured: day 30, day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start28 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinique de l'Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261320
- Sponsor's protocol ID
- 2023-506950-18-00
- Other IDs
- 2023
- Acronym
- MESOCOLO
- Status last verified
- May 2025
- First submitted
- 7 Feb 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesotherapy Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06261320
- Acronym / sponsor ID
- MESOCOLO / 2023-506950-18-00
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- mesotherapy, inflammatory bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Polyclinique de l'EuropeUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics. | Drug | Experimental group |
Primary outcome
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.
4 secondary outcomes
Functional Digestive Disorders Quality of Life questionnaire (FDDQL)
Time frame: day 30, day 45
Pain evaluation
Time frame: day 8, day 15, day 30, day 45
Global satisfaction
Time frame: day 45
Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"
Time frame: day 30, day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate in people with Inflammatory Bowel Diseases, run by Polyclinique de l'Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) (time frame: day 8, day 15, day 30, day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.