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H Pylori GastritisPhase 2NCT07179237

Efficacy of Carminal in Helicobacter Pylori Gastritis

A Phase 2 study testing Carminal Oral solution in people with H Pylori Gastritis and H Pylori Infection, run by Catalysis SL at 2 sites in Serbia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Eighty patients will be included and randomized in two groups, one group (40 patients) will be administered 30 ml of the supplement Carminal, once a day, plus therapy for HP gastitis and the control group (40 patients) will be given standard therapy for HP gastritis with placebo. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carminal Oral solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesSerbia
Study dates
4 Aug 2025to 5 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years or older
  • Patients with clinical symptoms of dyspepsia
  • Patients diagnosed with Helicobacter pylori positive gastritis, confirmed by upper endoscopy with histology
  • Patients who give written informed consent to participate in the study

Who cannot join

  • Patients with peptic ulcer disease
  • Patients with previous gastric surgery
  • Patients with current malignancy or the history of any previous malignancies
  • Patients taking another investigational product, or have taken any investigational product in the last year
  • Patients with known hypersensitivity to any ingredients found in the investigational product.
  • Decompensated intercurrent illnesses, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, and psychiatric illnesses that may limit adherence to the requirements of the clinical trial, or any other special condition that, according to the physician's judgement, jeopardises the patient's health or life during participation in the trial.
  • Planned pregnancy for the duration of trial, pregnancy, breast feeding, or postpartum period.
  • Patients with human immunodeficiency virus (HIV).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dragana Mijač, MD, PhD contact

+381 11 3088672

draganamijac@gmail.com

Serbia2 sites, 2 recruiting

  • Clinical Center of Serbia - Clinic for Gastroenterohepatology

    Belgrade, Central Serbia, 11000

    Dragana Mijač, MD, PhD, +381 11 3088672, draganamijac@gmail.com

    Aleksandra Marković-Pavlović, MD, PhD, +381 11 3662080

    Recruiting

  • Zvezdara Medical Center - Department of Gastroenterology

    Belgrade, Central Serbia, 11000

    Miloš Mitrović, MD, +381 11 3806 96, dr.milosh.mitrovic@gmail.com

    Miloš Mitrović, MD

    Recruiting

Other trials in Serbia

About this study

Official title: Evaluation of the Efficacy of Carminal on the Gastric Mucosa in Patients With Helicobacter Pylori Positive Gastritis

Eighty patients will be included and randomized in two groups, one group (40 patients) will be administered 30 ml of the supplement Carminal, once a day, plus therapy for HP gastitis and the control group (40 patients) will be given standard therapy for HP gastritis with placebo. Treatment will begin after complection of upper endoscopy with histology results from biopted gastric mucosa. Treatment with Carminal will be continued after successful HP eradication during 12 weeks. The final evaluation will take place 12 weeks after the last Carminal intake, when control endoscopy with histology will be performed. The study will last approximately 24 weeks.

Read the detailed description

Helicobacter pylori-induced gastritis is an infectious disease based on objective pathological criteria. After the successful eradication of the infection, the recovery of the mucosa occurs through a gradual process that lasts several months. HP eradication is a therapeutic modality for the treatment of non-atrophic gastritis, and it leads to the regression of atrophic gastritis and the reduction of the risk of gastric cancer. In patients with histologically verified intestinal metaplasia, HP eradication does not reduce the risk of malignancy, but reduces inflammation and atrophy, thereby slowing its further progression. It is considered that advanced changes of the mucosa are not fully reversible, while even atrophy can be reversible in certain cases. There are controversial data about reversibility of intestinal metaplasia. However, HP treatment is challenged by the continuously rising antibiotic resistance and demands for susceptibility testing with consideration of novel molecular technologies and careful selection of first line and rescue therapies. On the other hand, the role of HP and antibiotic therapies and their impact on the gut microbiota are also considered.

The Aloe vera plant (Aloe vera) is a well-known natural substance with several advantages. Aloe vera is frequently utilized as a fundamental component in medications and cosmetics, either directly or after being processed with additional substances. Aloe vera is a member of the Liliaceae family, which has over 200 species. Multiple preclinical studies have demonstrated that ingesting aloe vera juice in specific amounts may contribute to healing stomach ulcers and may be a natural cure for heartburn. Additionally, according to experimental studies aloe vera has the capacity to increase the production of pepsin, a stomach enzyme that aids in digestion. These findings suggest that using a combination of aloe vera with additional substances can have a synergistic antinflammatory and immunomodulatory effect in vivo on gastric mucosa and peptic ulcer disease on animal models.

Carminal, produced by Laboratorios Catalysis, S. L., is an oral solution and supplement that combines aloe vera extract and various substances known for their potential antioxidant, anti-inflammatory and immunomodulatory properties on gastric mucosa.

The goal of this study is to assess how Carminal affects the HP eradication and recovery of gastric mucosa after successful HP eradication and effect on related symptoms.

The trial will be conducted in accordance with the protocol, Good Clinical Practice (GCP) and in compliance with the regulations in force in the Republic of Serbia.

Being tested
Carminal Oral solution, Placebo
Keywords
Antioxidant, Aloe vera, Food Supplement, Helicobacter Pylori, Gastritis, Gastric mucosa
Medical subject headings
Gastritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carminal Oral solutionDietary supplement

    Also called Carminal, Carminal supplement, Carminal 30 ml vials

    Carminal is an oral dietary supplement presented in 30 ml vials, administered once daily (1 vial BID). It contains Aloe vera extract, olive extract, glutamic acid, zinc, and other components with potential antioxidant, anti-inflammatory, and immunomodulatory effects on gastric mucosa. In this study, Carminal is administered for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued treatment post-eradication to support mucosal recovery and improve dyspeptic symptoms.

  • PlaceboOther

    Also called Carminal Placebo, Placebo 30 ml vials

    Placebo is an oral solution presented in 30 ml vials, identical in appearance, taste, color, and smell to Carminal, but without any active ingredients. It is administered once daily (1 vial BID) for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued placebo treatment post-eradication. This comparator is used to evaluate the efficacy of Carminal in mucosal recovery and symptom improvement in patients with H. pylori positive gastritis.

Study groups in NCT07179237
Study groupRoleWhat they receive
Carminal GroupExperimentalParticipants in this arm (n=40) will receive: Carminal oral solution, 30 ml once daily (1 vial BID), administered for 14 days during standard Helicobacter pylori eradication therapy. Following successful eradication, Carminal treatment will continue for 12 additional weeks. Carminal is a supplement containing Aloe vera extract, olive extract, glutamic acid, zinc, and other components with potential antioxidant, anti-inflammatory, and immunomodulatory effects on gastric mucosa. The intervention aims to support mucosal recovery post-eradication and improve dyspeptic symptoms.
Receives: Dietary Supplement: Carminal Oral solution
Placebo GroupPlacebo comparatorParticipants in this arm (n=40) will receive: Placebo, matched in appearance and administration schedule to Carminal, for 14 days during standard H. pylori eradication therapy. Following successful eradication, placebo treatment will continue for 12 additional weeks. This arm serves as the control group to evaluate the efficacy of Carminal in mucosal recovery and symptom improvement.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glasgow Dyspepsia Severity Score

    Change in dyspeptic symptoms assessed using the Glasgow Dyspepsia Severity Score questionnaire at baseline, after eradication therapy, and at the end of Carminal/placebo treatment.

    Measured: Baseline, Week 7 (post-eradication), Week 20 (end of treatment)

  2. Endoscopic assessment of gastric mucosa

    Endoscopic evaluation of gastric mucosa performed before treatment and at the end of the study to assess mucosal recovery, including presence of gastritis, intestinal metaplasia, and other morphological changes.

    Measured: Baseline and Week 21

  3. Histological assessment of gastric mucosa

    Histological analysis of gastric biopsies to evaluate inflammation, atrophy, foveolar hyperplasia, and intestinal metaplasia before and after treatment.

    Measured: Baseline and Week 21

Secondary outcomes (4)

  1. Leeds Dyspepsia Score

    Change in dyspeptic symptoms assessed using the Leeds Dyspepsia Score questionnaire at baseline, after eradication therapy, and at the end of treatment.

    Measured: Baseline, Week 7, Week 20

  2. Helicobacter pylori status (HP antigen stool test)

    HP antigen presence in stool samples to confirm eradication success after 14-day standard therapy.

    Measured: Week 7

  3. Patient satisfaction after treatment completion

    Patient-reported satisfaction with treatment outcomes collected via questionnaire at the end of the study.

    Measured: Week 20

  4. Occurrence of adverse events

    Monitoring and recording of any adverse events (AEs), including type, duration, intensity, seriousness, and outcome.

    Measured: Throughout the study (Week 1 to Week 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start4 Aug 2025
  3. Primary completion3 Aug 2026 (estimated)
  4. Study completion5 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07179237
Sponsor's protocol ID
CARMINAL_HPYLORI_SERBIA2025
Status last verified
Sep 2025
First submitted
9 Sep 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol. 1996 Oct;20(10):1161-81. doi: 10.1097/00000478-199610000-00001.

    PubMed 8827022

  • Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.

    PubMed 26187502

  • Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.

    PubMed 35944925

  • Wang C, Yuan Y, Hunt RH. The association between Helicobacter pylori infection and early gastric cancer: a meta-analysis. Am J Gastroenterol. 2007 Aug;102(8):1789-98. doi: 10.1111/j.1572-0241.2007.01335.x. Epub 2007 May 23.

    PubMed 17521398

  • Graham DY. History of Helicobacter pylori, duodenal ulcer, gastric ulcer and gastric cancer. World J Gastroenterol. 2014 May 14;20(18):5191-204. doi: 10.3748/wjg.v20.i18.5191.

    PubMed 24833849

  • Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.

    PubMed 27769562

  • Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.

    PubMed 28456631

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carminal Oral solution in people with H Pylori Gastritis and H Pylori Infection, run by Catalysis SL at 2 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dragana Mijač, MD, PhD (+381 11 3088672, draganamijac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glasgow Dyspepsia Severity Score (time frame: Baseline, Week 7 (post-eradication), Week 20 (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07179237, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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