Quality of life and safety of CARMINAL® nutritional supplement in patients with mild or moderate ulcerative colitis

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:

Exploratory, multicenter, controlled, randomized, double-blind clinical trial to evaluate the quality of life and safety of the nutritional supplement CARMINAL® in combination with conventional therapy vs. placebo in patients with ulcerative colitis in mild or moderate activity.

Secondary indentifying numbers:

CAT-2022-2

Issuing authority of the secondary identifying numbers:

National Coordinating Center for Clinical Trials

Source(s) of monetary or material support:

Catalysis Laboratories, SL

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:

Others instances

Other regulatory instances:

National Institute of Hygiene, Epidemiology and Microbiology

Authorization date :

13/02/2024

Reference number:

Principal investigator

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

First name:

Maria

Midle name:

de los Angeles

Last name:

Camacho Morales

Medical Specialty :

First degree specialist in Comprehensive general medicine and first degree specialist in Gastroenterology

Affiliation:

Institute of Gastroenterology

Postal address:

Calle 25, 503 entre H e I, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-52834997

Email address:

maria.camacho@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:

Havana, Hermanos Ameijeiras Clinical Surgical Hospital, Dr. MSc. Jordi Alonso Soto, First degree specialist in Comprehensive general medicine and, First degree specialist in Gastroenterology

Havana, CIMEQ, Lissette Chao Gonzalez, MD, PhD. Second degree specialist of Gastroenterology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

13/03/2024

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:

Ulcerative colitis

Intervention(s):

Carminal Group (experimental): Carminal + Standard therapy. Carminal will be administered one vial (30 ml), oral solution, every 12 hours, administered with breakfast and lunch for 6 months Placebo group (control): Placebo + Standard therapy. The placebo will have the same administration route, frecuencay and duration to Carminal.

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):

Quality of life (IBDQ-32 Questionnaire. It has 32 items distributed in 4 dimensions: digestive symptoms (10 items), systemic symptoms (five items), emotional affectation (five items) and social (12 items). The responses to each item are expressed on a 7-point scale, where 7 corresponds to the best perception of health-related quality of life. A score is calculated for all items and a score for each dimension). Measurement time: At baseline and, a week after end of treatment

Key secondary outcomes:

Activity and Severity of Ulcerative Colitis 1. Symptoms (Frequency of stools (Formed stools, between 1 and 3 stools/day (unformed), between 4 and 6 stools/day, between 7 and 10 stools/day, more than 10 stools/day), Bleeding in stools (None, intermittent, frequent or continuous), Urgency to defecate: never, occasionally, frequently, continually)). Measurement time: At baseline, month 3 and one week after end of treatment 2. Laboratory parameters (Fecal Calprotectin (Negative, Positive), Hemoglobin (Normal, Dis, Transfusion requirements), Erythrocyte sedimentation rate (Normal, Elevated), Quantitative C-reactive protein (Normal, Elevated)). Measurement time: At baseline, month 3 and one week after end of treatment 3. Other laboratory parameters that measure inflammatory activity (Total leukocyte count (Normal, Elevated), Neutrophils (Normal, Elevated), Lymphocytes (Normal, Elevated), Platelets (Normal, Elevated), Albumin (Normal, Elevated)). Time measurement: At baseline, month 3 and one week after the end of treatment Clinical response 1. Clinical remission (Simple Colitis Activity Index, SCCAI. The category “Remission” is established when the total score is less than or equal to 2 points. The category “Active disease” is established when the total score is greater than 2 points). Measurement time: at baseline, month 3 and one week after the end of treatment 2. Clinical improvement (Simple Colitis Activity Index, SCCAI). The categories are established: Improvement when the final total score, with respect to the baseline value, decreases by 3 or more points, No improvement-Stable when the change in the score is not greater than 2 points with respect to the baseline value and No improvement-worse when the final total score increases by 3 points or more with respect to the baseline value score). Measurement time: at baseline, month 3 and one week after the end 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:

1. Patients who meet the diagnostic criteria. 2. Patients aged ≥ 19 years. 3. Patients who have signed the informed consent for the research.

Exclusion criteria:

1. Patients with neuropsychiatric disorders that prevent the patient from expressing their willingness to participate in the study or hinder their evaluation. 2. Patients with hypersensitivity or a history of allergy to Carminal® or some of its components. 3. Patients with decompensated chronic diseases (diabetes mellitus, venous insufficiency, arterial hypertension, bronchial asthma, interstitial fibrosis, chronic renal failure, ischemic heart disease, symptomatic congestive heart failure, aortic stenosis, endocarditis, unstable angina pectoris, cardiac arrhythmia). 4. Patient who is participating in another clinical trial or receiving another investigational product at the time of selection.

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:

N/A

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:

Anaelys

Last Name:

Maceo Sinabele

Specialty:

Bachelor degree in Pharmaceutical Sciences. Clinical Research Assistant

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164221

Email :

anaelys@cencec.sld.cu [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:

Ivis

Middle Name:

Cristina

Last Name:

Mendoza Hernandez

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master in Pharmacology and, Master in Clinical Trials

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5ta A e/ 60 y 6, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@cencec.sld.cu [3]

Research Ethics Committees

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

Name of Research Ethics Committees:

Hermanos Ameijeiras Clinical Surgical Hospital

CIMEQ

Institute of Gastroenterology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

14/02/2024

15/02/2024

24/01/2024

Postal address of Ethic Committee :

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

Calle 216 y 11b, Siboney, Playa, Havana, ZC:12100, Cuba

Calle 25, 503 entre H e I, Plaza de la Revolucion, Havana, ZC:10400, Cuba

Telephone:

+53-78761000

+53-78581000

+53-78322691

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

05/03/2025

Date of available results:

30/09/2025

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:

RPCEC00000434

Date of Registration in Primary Registry:

29/02/2024

Record Verification Date:

2024/02/29

Next update date:

2025/02/29

Link to the spanish version:

Click here [4]