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

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Weight Loss

Treatments: Biological: Probiotics; Procedure: PENS T6

Study type: Interventional

Funder types: Other

Identifiers

NCT03872245

Garcilaso 19-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI > 30 Kg/m2

Exclusion criteria

• Patients with pacemakers or implanted electrical devices.
• Pregnant women
• History of allergy to Probiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PENS T6 + Probiotics

Experimental group

Description:

The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.

Treatment:

Procedure: PENS T6

Biological: Probiotics

PENS T6

Active Comparator group

Description:

The patients will undergo PENS T6 during 10 weeks.

Treatment:

Procedure: PENS T6