Effect of the probiotic supplement EDC-HHA01 (OptiBiotics Plus) in the treatment of Type 2 Diabetes Mellitus.

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.

Scientific title:

Secondary indentifying numbers:

Not Applicable

Issuing authority of the secondary identifying numbers:

Not Applicable

Source(s) of monetary or material support:

EDC BioSynergy LLC Companny, EDC BioSynergy LLC,1854 Castillo Court, San Luis Obispo, California, 93405-6147 USA

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:

Gissel

Last name:

Garcia Menendez

Medical Specialty :

Biochemistry, PhD

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 corner Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-77682423

+53-52706385

Email address:

gisselgarcia2805@gmail.com

gisselgarcia@infomed.sld.cu

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:

Cuba

Clinical sites:

Not Applicable

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

02/12/2024

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:

Type 2 Diabetes Mellitus

Intervention(s):

Group I (Experimental): Optibiotic Plus. The patient will receive a capsule of 250 mg of viable and non-viable material (150 mg of viable bacteria). The capsule will be received every 12 hours, by oral route, for 6 months Group II. (Control): Placebo. The patient will receive a capsule of 250 mg of Microcrystalline cellulose. The capsule will be received every 12 hours, by oral route, for 6 months

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):

Glycated hemoglobin A1c (HbA1c) levels (Values expressed in %). Measurement time: At baseline, 3 months and 6 months

Key secondary outcomes:

1. Fasting glucose (expressed value in mMol/L). Measurement time: At baseline, 3 months and 6 months 2. Cholesterol (expressed value in mmol/L). Measurement time: At baseline, 3 months and 6 months 3. Triglycerides (expressed value in mmol/L). Measurement time: At baseline, 3 months and 6 months 4. Insulin (expressed value in mUI/ml). Measurement time: At baseline, 3 months and 6 months 5. Homa Index (Insulin Resistance Index) (Insulin levels (Fasting U/ml)* Glucose levels (Fasting mmol/L)/22.5). Measurement time: At baseline, 3 months and 6 months

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1- Type 2 diabetic and prediabetic individuals from all over the country who attend the specialized consultations of the Hermanos Ameijeiras Hospital, over 18 years of age, without distinction of sex or skin color and who give their consent to participate in the study 2-Diabetic individuals who only have oral antihyperglycemic treatments. 3- Do not ingest probiotics at the time of study recruitment.

Exclusion criteria:

1- Type 2 diabetic individuals with insulin treatment. 2-Individuals with type 1 or other Diabetes. 3- Medical alterations that could simulate the symptoms of Type 2 Diabetes Mellitus (T2DM) 4-Active or uncontrolled co-morbidities (including depression, untreated endocrine diagnosis, recent acute infection), which in the physician's opinion could interfere with the patient's ability to participate in the study. 5-Pregnancy or breastfeeding period. 6-Kidney failure or evidence of substance abuse. 7-Participate in other clinical treatments or improvement of symptoms as a result of treatment interventions three months previously

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1

Target sample size:

100

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:

Gissel

Last Name:

Garcia Menendez

Specialty:

Biochemistry, PhD

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia2805@gmail.com

gisselgarcia@infomed.sld.cu

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:

Gissel

Last Name:

Garcia Menendez

Specialty:

Biochemistry, PhD

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia2805@gmail.com

gisselgarcia@infomed.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Hermanos Ameijeiras Clinical Surgical Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/04/2024

Postal address of Ethic Committee :

Calle San Lazaro # 701 esq. a Belascoain, Centro Habana, Havana, Z.C:10400, Cuba

Telephone:

+53-78761210

Email:

alvaca@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/01/2025

Date of available results:

30/04/2025

Date of first publication:

30/06/2025

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:

RPCEC00000441

Date of Registration in Primary Registry:

30/05/2024

Record Verification Date:

2024/12/10

Next update date:

2025/12/10

Link to the spanish version:

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Effect of the probiotic supplement EDC-HHA01 (OptiBiotics Plus) in the treatment of Type 2 Diabetes Mellitus.

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