Dietary food supplement Helinorm containing L.reuteri DSM 17648 in eradication treatment inH.pylori-positive patients with functional dyspepsia

Not Applicable

Completed

• Conditions: Digestive System; ?onfirmed diagnosis of functional dyspepsia according to Rome IV criteria and presence of H. pylori infection according to 13C-UBT; Functional dyspepsia

• Registration Number: ISRCTN20716052
• Lead Sponsor: izhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39023173/ (added 19/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Study Completion: 2022-01-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 172

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence and Absence of H. pylori will be confirmed by 13C-UBT test at Visit 1 (Screening) and Visit 4 (End of study)