Weight LossPhase 3NCT03872245
Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
A Phase 3 study testing Probiotics and PENS T6 in people with Weight Loss, run by Hospital General Universitario Elche.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Probiotics and PENS T6
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2019to 31 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30 Kg/m2
Who cannot join
- Patients with pacemakers or implanted electrical devices.
- Pregnant women
- History of allergy to Probiotics
Trial locations and contacts
No sites are listed yet.
Oscar Lorenzo contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Probiotics, PENS T6
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsBiological
The patients will receive Adomelle 1caps/12h during 10 weeks
PENS T6Procedure or surgery
The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| PENS T6 + Probiotics | Experimental | The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks. Receives: Biological: Probiotics; Procedure: PENS T6 |
| PENS T6 | Active comparator | The patients will undergo PENS T6 during 10 weeks. Receives: Procedure: PENS T6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss after treatment will be assessed
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start11 Mar 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Carolina Llavero, Study director, Hospital Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872245
- Sponsor's protocol ID
- Garcilaso 19-3
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
- ClinicalTrials.gov ID
- NCT03872245
- Acronym / sponsor ID
- Garcilaso 19-3
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 11 Mar 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENS T6 + Probiotics | Experimental | Biological: Probiotics, Procedure: PENS T6The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks. |
| PENS T6 | Active comparator | Procedure: PENS T6The patients will undergo PENS T6 during 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 30 Kg/m2
Key exclusion criteria (3 listed)
- Patients with pacemakers or implanted electrical devices.
- Pregnant women
- History of allergy to Probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsThe patients will receive Adomelle 1caps/12h during 10 weeks | Biological | PENS T6 + Probiotics |
| PENS T6The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks | Procedure or surgery | PENS T6, PENS T6 + Probiotics |
Primary outcome
Weight loss
Time frame: 10 weeks
Weight loss after treatment will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Lorenzo contact
Carolina Llavero study director
Hospital Rey Juan Carlos
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotics and PENS T6 in people with Weight Loss, run by Hospital General Universitario Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Ruiz-Tovar (630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.