Safety of Orally Administered Neutral pH Super Oxidation Electrolyzed Solution

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ORALSES

Scientific title:

Safety evaluation of orally administered superoxidation electrolyzed solution with neutral pH in clinically healthy subjects or without decompensated diseases

Acronym of Scientific Title:

ORALSES

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Esteripharma Laboratory

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ivan

Last name:

Delgado Enciso

Medical Specialty :

General Medicine. Specialist in Molecular Biology

Affiliation:

University of Colima (UCOL), Mexico.

Postal address:

Avenue Universidad 333, Colonia Las viboras.

City:

Colima

Country:

Mexico

Zip Code:

28040

Telephone:

+52-3121521435

Email address:

ivan_delgado_enciso@ucol.mx [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

14/08/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Healthy

Health condition(s) code:

Healthy Volunteers

Intervention(s):

Single group: The patient will receive orally 30 milliliters of Neutral pH Super Oxidation Electrolyzed Solution (also called neutral electrolyzed Saline), administered every 8 hours, for 10 days. The solution should be ingested 30 minutes before, or two hours after, any solid or semi-solid food, or medication, without restriction regarding other liquids. Five days after the last dose of the Neutral pH Super Oxidation Electrolyzed Solution (day 15), a probiotic suspension with 4 billion colony-forming units of Bacillus Clausii was administered orally.

Intervention code:

Saline Solution

Probiotics

Administration, Oral

Intervention keyword:

electrolyzed solution

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse Events-AE (Present, Absent). AEs will be classified according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE). Measurement time: Daily until the 15th or until the AEs that arise are resolved.

Key secondary outcomes:

Change in blood serum laboratory test values (Na, K, Cl, prothrombin time, partial thromboplastin time, cholesterol, triglycerides, glucose, urea, creatinine, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, albumin, bilirubin, lactate dehydrogenase biometry), in whole blood (hematic biometry and erythrocyte sedimentation rate), in feces (coproparasitoscopic and stool analysis), and in urine (general urinalysis, protein, creatinine, and Na in a random urine sample). Measurement time for serum and whole blood analysis: Basal, 5 and 10 days. Measurement time for analysis in feces and urine: Basal and after 10 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

45 years

Inclusion criteria:

1. Age between 18 and 45 years. 2. That they do not present signs or symptoms of an acute illness. 3 In case of suffering from any chronic degenerative disease, which is controlled and without presenting complications. 4. Sign informed written consent voluntarily.

Exclusion criteria:

1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Previously diagnosed heart disease (ischemic). 4. Decompensated systemic chronic disease. 5. Creatinine 1.25 times higher than the normal value or creatinine clearance less than 50 milliliters/minute (Cockfrot and Gault method). 6. Blood hemoglobin less than 10g/Dl. 7. Increase in the last month of diastolic blood pressure of 110 mmHg or more and/or appearance of hematuria or proteinuria greater than 300 milligrams/day. 8. Intestinal pseudo-obstruction. Defined as abdominal pain, with air-fluid levels on AP abdominal radiographs and standing lateral. 9. Pregnant and lactating women. 10. Drug addiction (illegal drugs). 11. Known liver disease with doubling of liver function tests (Aspartate amino transferase (AST), Alanine amino transferase (ALT), Alkaline phosphatase, Bilirubin). 12. Presence of Cancer. 13. Other pathologies at the discretion of the researcher.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Other purpose:

Safety

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Brenda

Middle Name:

Astrid

Last Name:

Paz-Michel

Specialty:

Biomedical Research and Chemical Sciences

Affiliation:

Esteripharma Laboratory

Postal Address:

Libramiento Jorge Jiménez Cantú Oriente 412, Colonia 2 de Abril.

City:

Atlacomulco, Estado de Mexico.

Country:

Mexico

Zip Code:

50450

Telephone:

+52-7121204517

Email :

bpaz@esteripharma.com.mx [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ivan

Last Name:

Delgado Enciso

Specialty:

General Medicine. Specialist in Molecular Biology

Affiliation:

University of Colima (UCOL), Mexico.

Postal Address:

Avenue Universidad 333, Colonia Las viboras.

City:

Colima

Country:

Mexico

Zip Code:

28040

Telephone:

+52-3121521435

Email :

ivan_delgado_enciso@ucol.mx [1]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Research Ethics Committee of the State Institute of Cancerology of Colima, Mexico

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

23/06/2023

Postal address of Ethic Committee :

Avenue Liceo de Varones 401, Colonia La Esperanza, ZC 28085 Colima, Mexico

Telephone:

+52-3123162740

Email:

ceicancerologiacolima@hotmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/09/2023

Date of available results:

31/01/2024

Date of first publication:

28/02/2024

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000427

Date of Registration in Primary Registry:

21/07/2023

Record Verification Date:

2023/07/21

Next update date:

2024/07/21

Link to the spanish version:

Click here [3]