ISRCTN20716052
Completed
N/A
This multicenter, double-blind, randomized, placebo-controlled clinical evaluation is planned to determine the efficacy and safety of the use of dietary food supplements HELINORM against the background of the standard first-line eradication therapy regimen (ESO + AMO + CLA) on for 14 days followed by the use for 14 days in H. pylori-positive adult patients with functional dyspepsia
izhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)0 sites172 target enrollmentJanuary 20, 2020
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ?onfirmed diagnosis of functional dyspepsia according to Rome IV criteria and presence of H. pylori infection according to 13C-UBT
- Sponsor
- izhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)
- Enrollment
- 172
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39023173/ (added 19/07/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female aged 18 to 65
- •2\. For women of childbearing potential: mandatory use of contraceptive methods
- •3\. Confirmed diagnosis of functional dyspepsia according to Rome IV criteria
- •4\. Presence of H. pylori infection according to 13C\-UBT
- •5\. Able to understand and willing to complete all protocol details
- •6\. No history of previous eradication therapy at least a year before the screening
- •7\. Signed informed consent
Exclusion Criteria
- •1\. Erosive and ulcerative changes of the gastric and/or duodenal mucosa
- •2\. Cicatricial changes of the gastric and/or duodenal mucosa
- •3\. History of eradication therapy less than 1 year before screening
- •4\. Use of antibiotics and/or bismuth tripotassium dicitrate and/or H2\-blockers and/or proton pump inhibitors 30 days before and during the trial (except for treatment according to the protocol)
- •5\. Use of macrolide antibiotics less than 1 year before screening
- •6\. Any severe, decompensated or unstable somatic disease that may affect the clinical evaluation of the investigational product or put the patient at risk
- •7\. Alcohol or drug use
- •8\. Pregnancy, lactation
- •9\. Known sensitivity to any components of the investigational product and to any of the medicinal products prescribed in this trial
- •10\. History of stomach surgery, small intestine resection or pancreas surgery
Outcomes
Primary Outcomes
Not specified
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