Association of Probiotics With Neurostimulation of Dermat... | NCT03872245

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

NCT03872245

Sponsor

Hospital General Universitario Elche

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

20Estimated

Phase

Phase 3

Conditions

Weight Loss

Interventions

Probiotics
PENS T6

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Estimated

Primary Completion Date

May 31, 2019Estimated

Completion Date

May 31, 2019Estimated

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PENS T6 + Probiotics	Experimental	The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.	Biological: Probiotics Procedure: PENS T6
PENS T6	Active Comparator	The patients will undergo PENS T6 during 10 weeks.	Procedure: PENS T6

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Biological	The patients will receive Adomelle 1caps/12h during 10 weeks	PENS T6 + Probiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss	Weight loss after treatment will be assessed	10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI > 30 Kg/m2

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jaime Ruiz-Tovar	Contact	630534808		jruiztovar@gmail.com
Oscar Lorenzo	Contact			Olorenzo@fjd.es

Overall Officials

Name	Affiliation	Role
Carolina Llavero	Hospital Rey Juan Carlos	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided