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

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Probiotics
PENS T6
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 30 Kg/m2

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PENS T6 + Probiotics

    PENS T6

    Arm Description

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

    The patients will undergo PENS T6 during 10 weeks.

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight loss after treatment will be assessed

    Secondary Outcome Measures

    Full Information

    First Posted
    March 11, 2019
    Last Updated
    March 11, 2019
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03872245
    Brief Title
    Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
    Official Title
    Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 11, 2019 (Anticipated)
    Primary Completion Date
    May 31, 2019 (Anticipated)
    Study Completion Date
    May 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PENS T6 + Probiotics
    Arm Type
    Experimental
    Arm Description
    The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
    Arm Title
    PENS T6
    Arm Type
    Active Comparator
    Arm Description
    The patients will undergo PENS T6 during 10 weeks.
    Intervention Type
    Biological
    Intervention Name(s)
    Probiotics
    Intervention Description
    The patients will receive Adomelle 1caps/12h during 10 weeks
    Intervention Type
    Procedure
    Intervention Name(s)
    PENS T6
    Intervention Description
    The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight loss after treatment will be assessed
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI > 30 Kg/m2 Exclusion Criteria: Patients with pacemakers or implanted electrical devices. Pregnant women History of allergy to Probiotics
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jaime Ruiz-Tovar
    Phone
    630534808
    Email
    jruiztovar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Oscar Lorenzo
    Email
    Olorenzo@fjd.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carolina Llavero
    Organizational Affiliation
    Hospital Rey Juan Carlos
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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