Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2019
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2019
CompletedStudy Start
First participant enrolled
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedMarch 13, 2019
March 1, 2019
3 months
March 11, 2019
March 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss
Weight loss after treatment will be assessed
10 weeks
Study Arms (2)
PENS T6 + Probiotics
EXPERIMENTALThe patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
PENS T6
ACTIVE COMPARATORThe patients will undergo PENS T6 during 10 weeks.
Interventions
The patients will receive Adomelle 1caps/12h during 10 weeks
The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
Eligibility Criteria
You may qualify if:
- BMI \> 30 Kg/m2
You may not qualify if:
- Patients with pacemakers or implanted electrical devices.
- Pregnant women
- History of allergy to Probiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carolina Llavero
Hospital Rey Juan Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
March 11, 2019
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
March 13, 2019
Record last verified: 2019-03