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

NCT ID: NCT03872245

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PENS T6 + Probiotics

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

Group Type EXPERIMENTAL

Probiotics

Intervention Type BIOLOGICAL

The patients will receive Adomelle 1caps/12h during 10 weeks

PENS T6

Intervention Type PROCEDURE

The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks

PENS T6

The patients will undergo PENS T6 during 10 weeks.

Group Type ACTIVE_COMPARATOR

PENS T6

Intervention Type PROCEDURE

The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks

Interventions

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Probiotics

The patients will receive Adomelle 1caps/12h during 10 weeks

Intervention Type BIOLOGICAL

PENS T6

The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30 Kg/m2

Exclusion Criteria

* Patients with pacemakers or implanted electrical devices.
* Pregnant women
* History of allergy to Probiotics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina Llavero

Role: STUDY_DIRECTOR

Hospital Rey Juan Carlos

Central Contacts

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Jaime Ruiz-Tovar

Role: CONTACT

630534808

Oscar Lorenzo

Role: CONTACT

Other Identifiers

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Garcilaso 19-3

Identifier Type: -

Identifier Source: org_study_id

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