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

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ClinicalTrials.gov Identifier: NCT03872245
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, 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.


Condition or disease Intervention/treatment Phase
Weight Loss Biological: Probiotics Procedure: PENS T6 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
Estimated Study Start Date : March 11, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Weight loss [ Time Frame: 10 weeks ]
    Weight loss after treatment will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 30 Kg/m2

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872245


Contacts
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Contact: Jaime Ruiz-Tovar 630534808 jruiztovar@gmail.com
Contact: Oscar Lorenzo Olorenzo@fjd.es

Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Carolina Llavero Hospital Rey Juan Carlos

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03872245     History of Changes
Other Study ID Numbers: Garcilaso 19-3
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes