Evaluation of the effects and safety of Abexol (suspension vs tablets) in adults with functional dyspepsia

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:

Evaluation of the effects and safety of Abexol (suspension) versus Abexol (tablets) in adult patients with functional dyspepsia

Secondary indentifying numbers:

AbeS/AbeT-DF-01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Centre for Scientific Research (CNIC)

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:

Tania

Last name:

Sandrino Ortiz

Medical Specialty :

First Degree Specialist in Gastroenterology

Affiliation:

"Manuel Fajardo" Clinical-Surgical Teaching Hospital

Postal address:

Calle D / 29 y Zapata, Vedado, Plaza de la Revolucion.

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-59425139

Email address:

tania.sandrino@infomed.sld.cu [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:

02/11/2026

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:

Functional dyspepsia

Health condition(s) code:

Dyspepsia

Signs and Symptoms, Digestive

Digestive System Diseases

Health condition keyword:

Intervention(s):

Group 1 Abexol-tablet (Experimental): A tablet of 50 mg by oral route, three times daily, an hour before breakfast, lunch, and dinner for 8 weeks. Group 2 Abexol-suspension (Experimental): A tablespoon of 5 mL approximately by oral route, three times daily, an hour before breakfast, lunch, and dinner for 8 weeks.

Intervention code:

Dietary Supplements

Tablets

Suspensions

Administration, Oral

Intervention keyword:

Abexol

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):

Dypepsia symptoms (Bisbal and Barúa Dyspepsia Test score). Measurement time: At baseline, and 2, 4, 6 and 8 weeks of treatment

Key secondary outcomes:

Quality of Life (SF-36 Quality of Life Questionnaire score). Measurement time: At baseline and 8 weeks of treatment

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:

The sample will consist of male and female patients aged 19 years or older with functional dyspepsia who attend outpatient consultations at the "Manuel Fajardo" Clinical-Surgical Teaching Hospital and agree to participate in the study. Patients meeting the Rome IV criteria for functional dyspepsia who have undergone a normal upper gastrointestinal endoscopy within the 12 months prior to the study will be included.

Exclusion criteria:

Inglés 1) A prior, confirmed diagnosis of *Helicobacter pylori*. 2) Organic lesions of the upper digestive tract requiring specific treatment. 3) Benign or malignant digestive neoplasms. 4) Alarm symptoms (gastrointestinal bleeding, anemia, significant weight loss, progressive dysphagia, odynophagia, persistent vomiting, lymphadenopathy, palpable abdominal mass). 5) Active liver or kidney disease. 6) Other non-digestive neoplasms. 7) Pancreatic conditions (acute pancreatitis or acute exacerbation of chronic pancreatitis). 8) Intrahepatic or extrahepatic biliary tract disorders. 9) Psychiatric disorders. 10) Glucose > 7 mmol/L, AST and ALT > 55 IU, and/or creatinine > 130 µmol/L. 11) Alcohol consumption (apply AUDIC; patients scoring ≥3 for women or ≥4 for men are excluded). 12) Patients with any other special condition that, in the physician's judgment, poses a risk to their health or life during the study.

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 trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

N/A

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:

Tania

Last Name:

Sandrino Ortiz

Specialty:

First Degree Specialist in Gastroenterology

Affiliation:

"Manuel Fajardo" Clinical-Surgical Teaching Hospital

Postal Address:

Calle D / 29 y Zapata, Vedado. Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-59425139

Email :

tania.sandrino@infomed.sld.cu [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:

Julio

Middle Name:

César

Last Name:

Fernandez Travieso

Specialty:

Pharmaceutical Science Degree

Affiliation:

National Centre for Scientific Research (CNIC)

Postal Address:

Avenida 15 y 158, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

"Manuel Fajardo" Clinical-Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

08/09/2026

Postal address of Ethic Committee :

Calle D / 29 y Zapata, Vedado. Plaza de la Revolucion, ZC: 10400, Havana. Cuba

Telephone:

+53-78382462

Correo electrónico:

dirección@hmfa.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/03/2027

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:

RPCEC00000488

Date of Registration in Primary Registry:

26/10/2026

Record Verification Date:

2026/10/26

Next update date:

2027/10/26

Link to the spanish version:

Click here [3]