Efficacy of Carminal in Helicobacter Pylori Gastritis

NCT07179237 | Recruiting Phase 2

• 1 other identifier: CARMINAL_HPYLORI_SERBIA2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

H Pylori Gastritis; H Pylori Infection; H Pylori Eradication; Gastritis Associated With Helicobacter Pylori; Gastric Mucosal Lesion

Keywords

Antioxidant; Aloe vera; Food Supplement; Helicobacter Pylori; Gastritis; Gastric mucosa

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

  Baseline and Week 21

• Histological assessment of gastric mucosa

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

  Baseline and Week 21

Secondary Outcomes (4)

• Leeds Dyspepsia Score

  Baseline, Week 7, Week 20

• Helicobacter pylori status (HP antigen stool test)

  Week 7

• Patient satisfaction after treatment completion

  Week 20

• Occurrence of adverse events

  Throughout the study (Week 1 to Week 21)

Study Arms (2)

Carminal Group

EXPERIMENTAL

Participants 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.

Dietary Supplement: Carminal Oral solution

Placebo Group

PLACEBO COMPARATOR

Participants 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.

Other: Placebo

Interventions

Carminal Oral solution DIETARY_SUPPLEMENT

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.

Also known as: Carminal, Carminal supplement, Carminal 30 ml vials

Carminal Group

Placebo OTHER

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.

Also known as: Carminal Placebo, Placebo 30 ml vials

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (2)

Clinical Center of Serbia - Clinic for Gastroenterohepatology

Belgrade, Central Serbia, 11000, Serbia

RECRUITING

Zvezdara Medical Center - Department of Gastroenterology

Belgrade, Central Serbia, 11000, Serbia

RECRUITING

Related Publications (7)

• 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.

  PMID: 8827022 BACKGROUND

• 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.

  PMID: 26187502 BACKGROUND

• 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 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.

  PMID: 35944925 BACKGROUND

• 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.

  PMID: 17521398 BACKGROUND

• 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.

  PMID: 24833849 BACKGROUND

• 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.

  PMID: 27769562 BACKGROUND

• 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.

  PMID: 28456631 BACKGROUND

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Dragana Mijač, MD, PhD

  Clinic for Gastroenterohepatology, Clinical Center of Serbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dragana Mijač, MD, PhD

CONTACT

+381 11 3088672; draganamijac@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

SE (2)