Effect of the high-precision symbiotic formulation OptiGutPro EDC-HHA02 in treatment of Idiopathic Inflammatory Bowel Disease

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:

NA241LH0073

Issuing authority of the secondary identifying numbers:

Hermanos Ameijeiras Clinical Surgical Hospital

Source(s) of monetary or material support:

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 :

Biochemestry, Master in Virology, Doctor in Health Sciences.

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78761630

+53-78761229

Email address:

gisselgarcia2805@gmail.com [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:

Cuba

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:

05/05/2025

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:

Inflammatory Bowel Disease

Intervention(s):

Group A - OPTIGUT PRO (Experimental group): Participants will receive a capsule of OPTIGUT PRO every 12 hours by oral route during 6 months. The capsule is a high-precision symbiotic formulation designed using Bioflux techniques, combining the action of four probiotic bacteria (Bacillus clausii AO1025, Bifidobacterium bifidum BB47, L. reuteri LE16, and L. gasseri LG23) and a prebiotic, inulin. Group B – Placebo (Control group): Participants will receive a capsule of placebo every 12 hours by oral route during 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):

Calprotectin Levels (It is considered a biomarker of intestinal inflammation. Increased levels correlate well with the progression of Crohn's disease. Fecal calprotectin concentrations below 100 μg/g reliably indicate patients with a low risk of clinical recurrence in endoscopic remission settings, for whom invasive endoscopic procedures can be avoided). Measurement time: At baseline and at 6 months.

Key secondary outcomes:

1. Quality of Life (SF-36 Health Survey in Spanish). Measurement time: At baseline and, 6 months 2. Adverse effect and its intensity (It will be measured by considering the presence of the adverse effect under four categories (No apparent adverse effect, Possible adverse effect, Similar to an adverse effect, Adverse effect) and its intensity classified into three categories (Mild, Moderate, Severe)). Measurement time: During the study, up to 6 months. 3. Muscle mass (The gain of muscle mass will be measured in grams using the TANITA bioimpedance device). Measurement time: At baseline and, at 6 months. 4. Inflammatory biomarker (IL-6 and C-Reactive Protein (CRP) will be measured. IL-6: Serum levels will be measured with normal range levels considered <5pg/ml. CRP: Serum levels will be measured with normal range levels considered between 0 and 5mg/L). Measurement time: At baseline, 3 months and, 6 months. 5. Blood chemistry (Serum levels will be evaluated considering the following normal ranges: GLUCOSE (3.3 - 6.1 mmol/L), CREATININE (47.6 - 113.4 μmol/L), CHOLESTEROL (<5.2 mmol/L), TRIGLYCERIDES (0.46 - 1.8 mmol/L), HDL (0.9 - 3 mmol/L), LDL (0 - 3.4 mmol/L), ALT (TGP)(<45 U/L), AST (TGO) (<40 U/L)). Measurement time: At baseline, 3 months and, 6 months. 6. Bacterial composition of the specific fecal microbiome (It will be determined by sequence studies of the 16S ribosome subunit (16S rRNA V3-V4) in stool samples from a group of randomly selected individuals from both groups. Taxonomic Profile and compositional analysis will be used. The taxonomic profile analysis will be performed using PICRUSt to determine the Inflammation Index, Alpha Diversity and Beta Diversity. The compositional analysis will be performed using the prediction analysis of functional markers (orthologous genes) from the study of the microbiome using LEfSe (Linear discriminant analysis Effect Size)). Measurement time: At baseline and at 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:

70 years

Inclusion criteria:

1. Adults aged between 19 and 70 years , regardless of sex or skin color, who provide their consent to participate in the study. 2. Individuals with a presumptive diagnosis of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) in the Gastroenterology services of the Gastroenterology Institute of Cuba, diagnosed through barium studies of the entire digestive tract (1-X-ray of esophagus, stomach, and duodenum; 2-Intestinal transit; 3-Colon enema, also known as barium enema), abdominal ultrasound (US), or abdominal computed tomography (CT), accompanied by calprotectin levels equal to or greater than 100 µg/g. 3. Not taking probiotic formulations at the time of enrollment in the study. 4. Fecal calprotectin levels less than or equal to 100 μg/g.

Exclusion criteria:

1. Individuals with intestinal alterations not yet classified within the two studied conditions. 2. Individuals with the studied dysbiosis who are taking any type of probiotic formulation at the start of the study. 3. Individuals who do not provide their consent to participate in the study. 4. Individuals who are taking TNF inhibitors, e.g., Humira.

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:

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:

Gissel

Last Name:

Garcia Menendez

Specialty:

Biochemestry, Master in Virology, Doctor in Health Sciences.

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-778761229

Email :

gisselgarcia2805@gmail.com [1]

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:

Biochemestry, Master in Virology, Doctor in Health Sciences.

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78751229

Email :

gisselgarcia2805@gmail.com [1]

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 :

San Lazaro # 701 esq. to Belascoain. Centro Habana. ZC: 10400, Havana. Cuba

Telephone:

+53-7876 1019

Correo electrónico:

direccion@hha.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/09/2026

Date of available results:

21/04/2027

Date of first publication:

15/02/2028

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:

RPCEC00000458

Date of Registration in Primary Registry:

30/04/2025

Record Verification Date:

2025/04/30

Next update date:

2026/04/30

Link to the spanish version:

Click here [2]