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NCT03872245 Clinical Trial

Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients

Weight Loss Clinical Trial

Official title:
Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03872245
Other study ID # Garcilaso 19-3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date March 11, 2019
Est. completion date May 31, 2019

Study information
Verified date March 2019
Source Hospital General Universitario Elche
Contact Jaime Ruiz-Tovar
Phone 630534808
Email jruiztovar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- BMI > 30 Kg/m2

Exclusion Criteria:

- Patients with pacemakers or implanted electrical devices.

- Pregnant women

- History of allergy to Probiotics

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Probiotics
The patients will receive Adomelle 1caps/12h during 10 weeks
Procedure:
• PENS T6
The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss Weight loss after treatment will be assessed 10 weeks
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