?onfirmed diagnosis of functional dyspepsia according to Rome IV criteria and presence of H. pylori infection according to 13C-UBT Digestive System Functional dyspepsia
Conditions
Interventions
Investigational products: Investigational dietary food supplement (DFS): HELINORM 324 mg capsules for oral administration. Dosage regimen: for adults: 1 capsule BID with meals. Duration of administrat
Sponsors
Nizhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Positive blood test for HIV and/or syphilis and/or HbsAg and/or HCVAb 12. Chronic diarrhea of various etiologies, except for functional diarrhea or IBS with diarrhea 13. Participation in another clinical trial 30 days before and during the trial 14. Use of probiotics, symbiotics, prebiotics for treatment of H. pylori infections and for other reasons 30 days before the start of trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence and Absence of H. pylori will be confirmed by 13C-UBT test at Visit 1 (Screening) and Visit 4 (End of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/02/2020: 1. Subjective evaluation of main disease (functional dyspepsia) will be performed using 7×7 and GSRS scores questionnaires at Visits 2 (Day 0, Start of Treatment), 3 (Day 14, End of Eradication treatment) and 4 (End of study) 2. Quality of life will be assessed using SF-36 questionnaire at Visits 2, 3 and 4 3. Adherence assessed using participant diary during each study visit (Visit 2, Visit 3 and Visit 4) 4. Adverse events (AEs) and serious adverse events (SAEs) assessed by asking the participants and recording them in the AE/SAE log during each study visit (Visit 2, Visit 3 and Visit 4) Previous secondary outcome measures: The following parameters were selected as secondary efficacy parameters in the clinical evaluation: 1. Subjective evaluation of main disease (functional dispepsia) will be performed using 7×7 and GSRS scores questionnaires at Visits 2 (Day 0, Start of Treatment), 3 (Day 14, End of Eradication treatment) and 4 (End of study) 2. Subjects Quality of Life will be assessed using SF-36 questionnaire at Visits 2, 3 and 4 | — |
Countries
Russian Federation
Contacts
Public ContactKirill Bessonov
Outcome results
None listed