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.

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.
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
ACTIVE_COMPARATOR: PENS T6
The patients will undergo PENS T6 during 10 weeks.
Procedure: PENS T6
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.

Sponsor

Hospital General Universitario Elche

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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