Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
Phase 3
- Conditions
- Weight Loss
- Interventions
- Biological: ProbioticsProcedure: PENS T6
- Registration Number
- NCT03872245
- Lead Sponsor
- Hospital General Universitario Elche
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- BMI > 30 Kg/m2
Exclusion Criteria
- Patients with pacemakers or implanted electrical devices.
- Pregnant women
- History of allergy to Probiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PENS T6 + Probiotics Probiotics The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks. PENS T6 PENS T6 The patients will undergo PENS T6 during 10 weeks. PENS T6 + Probiotics PENS T6 The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
- Primary Outcome Measures
Name Time Method Weight loss 10 weeks Weight loss after treatment will be assessed
- Secondary Outcome Measures
Name Time Method