Effects of H.Pylori Eradication on Microbiome

NCT03231332 | Unknown Phase 4

• 1 other identifier: 1.1.1.1/16/A/272
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this Project is, within the scope of industrial research, to evaluate the long term effects of H.pylori eradication on microbiome (gut microbiome, upper respiratory tract microbiome) and lasting adverse events. In addition, the project aims to evaluate its effects on abundance and prevalence of extended-spectrum beta-lactamases coding genes and develop cost effective ESBL screening test prototype.

Conditions

Human Microbiome

Keywords

Helicobacter pylori; Eradication; Microbiome; ESBL; GIT

Outcome Measures

Primary Outcomes (1)

• Effects of various H.pylori eradication regimens upon the gut microbiome

  Gut microbiome

  6-36 months between the initial and the follow-up sample

Secondary Outcomes (4)

• Effects of various H.pylori eradication regimens upon adverse events in short term

  21-28 days following the expected starting data of the treatmennt

• Effectiveness of various H.pylori eradication regimens

  1-12 months following eradication therapy

• Effects of various H.pylori eradication regimens upon the pharyngeal microbiome

  6-36 months between the initial and the follow-up sample

• Effects of various H.pylori eradication regimens upon long-lasting adverse events

  6 months - 10 years following eradication

Study Arms (3)

H.pylori Eradication index

EXPERIMENTAL

Microbiome diversity detection in Participants Positive for H.pylori and undergoing Eradication therapy with Clarythromycin-containing eradication therapy

Other: Microbiome Diversity detection

Control

NO INTERVENTION

Microbiome diversity detection in Participants Without H.pylori Eradication therapy

H.pylori Eradication comparative

ACTIVE COMPARATOR

Microbiome diversity detection in Participants Positive for H.pylori and undergoing Eradication therapy with high dose Amoxicillin and bismuth containing eradication therapy

Other: Microbiome Diversity detection

Interventions

Microbiome Diversity detection OTHER

detection of microbiome composition and detection of specific mutations in genes conferring resistance to antibiotics

H.pylori Eradication comparative; H.pylori Eradication index

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with established H.pylori infection
• Individuals in whom H.pylori eradication therapy is indicated according to the international or national recommendations
• Individuals who agree to undergo H.pylori eradication therapy

You may not qualify if:

• Severely sick patients
• Individuals in whom H.pylori eradication therapy is contra-indicated due to any reasons
• Individuals unable or unwilling to provide a sample for microbiome testing

Sponsors & Collaborators

• University of Latvia: lead
• Latvian Biomedical Research and Study Centre: collaborator

Study Sites (1)

University of Latvia

Riga, LV 1586, Latvia

Location

Related Publications (11)

• Herrero R, Parsonnet J, Greenberg ER. Prevention of gastric cancer. JAMA. 2014 Sep 24;312(12):1197-8. doi: 10.1001/jama.2014.10498. No abstract available.

  PMID: 25247512 BACKGROUND

• Schistosomes, liver flukes and Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. No abstract available.

  PMID: 7715068 BACKGROUND

• IARC, Monographs on the evaluation of carcinogenic risks to humans, volume 100. A review of carcinogen - Part B: biological agents. 2011, Lyon: International Agency for Research on Cancer.

  BACKGROUND

• Lee YC, Chen TH, Chiu HM, Shun CT, Chiang H, Liu TY, Wu MS, Lin JT. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut. 2013 May;62(5):676-82. doi: 10.1136/gutjnl-2012-302240. Epub 2012 Jun 14.

  PMID: 22698649 BACKGROUND

• Areia M, Carvalho R, Cadime AT, Rocha Goncalves F, Dinis-Ribeiro M. Screening for gastric cancer and surveillance of premalignant lesions: a systematic review of cost-effectiveness studies. Helicobacter. 2013 Oct;18(5):325-37. doi: 10.1111/hel.12050. Epub 2013 Apr 9.

  PMID: 23566268 BACKGROUND

• Lansdorp-Vogelaar I, Sharp L. Cost-effectiveness of screening and treating Helicobacter pylori for gastric cancer prevention. Best Pract Res Clin Gastroenterol. 2013 Dec;27(6):933-47. doi: 10.1016/j.bpg.2013.09.005. Epub 2013 Sep 27.

  PMID: 24182612 BACKGROUND

• Moayyedi, P., Feasibility and cost effectiveness of population-based H. pylori eradication, in In: IARC Helicobacter pylori Working Group. Helicobacter pylori Eradication as a Strategy for Preventing Gastric Cancer. Lyon, France: International Agency for Research on Cancer (IARC Working Group Reports, No. 8); pp. 174-180

  BACKGROUND

• Leja M, Cine E, Rudzite D, Vilkoite I, Huttunen T, Daugule I, Rumba-Rozenfelde I, Pimanov S, Liepniece-Karele I, Pahomova J, Purmalis K, Eglitis J, Pirags V, Dzerve V, Erglis A. Prevalence of Helicobacter pylori infection and atrophic gastritis in Latvia. Eur J Gastroenterol Hepatol. 2012 Dec;24(12):1410-7. doi: 10.1097/MEG.0b013e3283583ca5.

  PMID: 23114744 BACKGROUND

• Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

  PMID: 22491499 BACKGROUND

• Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H. Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet. 2007 Feb 10;369(9560):482-90. doi: 10.1016/S0140-6736(07)60235-9.

  PMID: 17292768 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 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Active treatment will be provided unmasked in the treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between intervention groups and the group without intervention will be made

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 27, 2017
• Study Start: July 29, 2017
• Primary Completion: October 29, 2019
• Study Completion: December 31, 2025
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

LA (1)