Effect of Antibiotic Antidote for Microbiome Restoration

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:

Effect of the symbiotic formulation Antibiotic Antidote on the restoration of intestinal microbiome balance and relief of post antibiotic diarrhea

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

The Biocollective llC, 5650 N. Washington Street, Unit C13, Denver, Colorado 80216, 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 :

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

+53-78765242

Email address:

gisselgarcia2805@gmail.com

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:

01/10/2026

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:

Post‑antibiotic diarrhea

Health condition(s) code:

Diarrhea

Intervention(s):

Group I – Antibiotic Antidote (Experimental): Participants will receive 2 capsules of Antibiotic Antidote daily by oral route, one at lunch and one at dinner, for 14 days. Group II – Placebo (Control): Participants will receive 2 capsules of Inulina daily by oral route, one at lunch and one at dinner, for 14 days.

Intervention code:

Dietary Supplements

Prebiotics

Placebo

Administration, Oral

Intervention keyword:

ANTIBIOTIC ANTIDOTE

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):

Time to resolution of diarrhea (Time from randomization until resolution of diarrhea. It will evaluate through the daily record of stool frequency and consistency using the Bristol Stool Scale, and verification of no use of rescue medication). Measurement time: At baseline and, on days 14, and 28.

Key secondary outcomes:

1. Microbiome diversity (16S sequencing of fecal samples and bioinformatic analysis of the results). Measurement time: At baseline and at 28 days 2. Gastrointestinal symptoms (GSRS questionnaire). Measurement time: At baseline and, on days 14, and 28. 3. Adverse Effects - AE (Presence of AE (No apparent AE, Possible AE, Similar to AE, AE); Intensity of AE (Mild: does not restrict daily activities, Moderate: partially restricts daily activities, Severe: inability to perform daily activities)). Measurement time: At baseline and, on days 14, and 28. 4. Quality of life (SF 36 questionnaire administered). Measurement time: At baseline and 28 days. 5. Liver enzymes (Value of Biochemical blood analysis using automated Cobas 6000 test). Measurement time: At baseline and at 28 days 6. Bilirubin (Value of Biochemical blood analysis using automated Cobas 6000 test). Measurement time: At baseline and at 28 days 7. Creatinine (Value of Biochemical blood analysis using automated Cobas 6000 test). Measurement time: At baseline and at 28 days 8. C reactive protein- CRP (Value of Biochemical blood analysis using automated Cobas 6000 test). Measurement time: At baseline and at 28 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:

19 years

Maximum age:

65 years

Inclusion criteria:

1- Adults between 19 and 65 years of age. 2- Completion of at least 7 days of systemic antibiotic treatment within the last 72 hours in patients who received therapies for H. pylori or urinary tract infections. 3- Presence of three or more liquid stools per day (Bristol classification 6–7) for a minimum period of 24 hours after antibiotic intake. 4- Ability to provide informed consent and comply with study procedures.

Exclusion criteria:

1-Chronic gastrointestinal diseases, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or celiac disease. 2-Use of probiotics or prebiotics within the last 30 days. 3-Immunocompromised status, including: HIV with CD4 count <200 cells/mm³; active treatment with chemotherapy, biologics, or chronic systemic steroids (≥10 mg prednisone or equivalent). 4-Pregnancy or breastfeeding. 5-Diagnosed chronic kidney disease. 6-Patients with diabetes mellitus, with or without metformin treatment.

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:

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

Email :

gisselgarcia2805@gmail.com

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:

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hospital Clínico Quirúrgico Hermanos Ameijeiras

Postal Address:

San Lazaro # 701 esq. a Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

Email :

gisselgarcia2805@gmail.com

Research Ethics Committees

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

Name of Research Ethics Committees:

Hermanos Ameijeiras Surgical Clinical Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

08/05/2026

Postal address of Ethic Committee :

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

Telephone:

+53-52833178

Email:

jorgeluishernandezcastro52@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/03/2027

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:

RPCEC00000483

Date of Registration in Primary Registry:

31/08/2026

Record Verification Date:

2026/08/31

Next update date:

2027/08/31

Link to the spanish version:

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Effect of Antibiotic Antidote for Microbiome Restoration

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