- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872245
Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
March 11, 2019 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
Patients will be randomized into 2 groups:
- Group 1:Patients undergoing PENS T6, who also received Probiotics, during 10 weeks.
- Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics
Weight loss after 10 weeks of treatmente will be assessed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized into 2 groups:
- Group 1:Patients undergoing percutaneous electrical stimulation of dermatome T6 (PENS T6), who also received Probiotics (Adomelle 1 caps/12h), during 10 weeks.
- Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics
Weight loss after 10 weeks of treatmente will be assessed.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oscar Lorenzo
- Email: Olorenzo@fjd.es
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 30 Kg/m2
Exclusion Criteria:
- Patients with pacemakers or implanted electrical devices.
- Pregnant women
- History of allergy to Probiotics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PENS T6 + Probiotics
The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
|
The patients will receive Adomelle 1caps/12h during 10 weeks
The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
|
ACTIVE_COMPARATOR: PENS T6
The patients will undergo PENS T6 during 10 weeks.
|
The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 10 weeks
|
Weight loss after treatment will be assessed
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Carolina Llavero, Hospital Rey Juan Carlos
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 11, 2019
Primary Completion (ANTICIPATED)
May 31, 2019
Study Completion (ANTICIPATED)
May 31, 2019
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (ACTUAL)
March 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Garcilaso 19-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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