A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05926804 |
Recruitment Status :
Recruiting
First Posted : July 3, 2023
Last Update Posted : January 5, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Helicobacter Pylori Infection | Drug: Lansoprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Metronidazole | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Screening phase: 14-18-year-old students (up to 1000) from three cities will be invited. After obtaining informed consent, eligible participants without exclusion criteria will undergo an H. pylori screening test (Urea Breath Test; UBT or stool antigen test; SAT). Those negative will exit, except for a subset to be followed as a non-infected controls. Subjects with a positive test will undergo two confirmatory tests 30 days apart to confirm infection persistence. Approximately 20-25% are expected to be positive. Intervention phase: those with persistent H. pylori infection will undergo gastroenterological evaluation 1 month before randomization (2:1) to receive antimicrobial treatment or no treatment. Non-infected controls will be followed at matched intervals. If untreated, subjects with persistent infection will be offered the eradication regimen after completing the initial 6-month follow-up with blood and stool samples taken. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Blinded Gastroenterologist or trained physician who performs the surveillance after eradication treatment. No other parties will be masked in the clinical trial. |
Primary Purpose: | Treatment |
Official Title: | A "Screen and Treat" Helicobacter Pylori Eradication Trial in 14-18 Years Old Adolescents Residing in Three Regions of Chile: Effectiveness and Microbiological-host Implications |
Actual Study Start Date : | August 2, 2022 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Cases
150-160 children with H. pylori-persistent infection, who will receive eradication therapy
|
Drug: Lansoprazole
14 days of Lansoprazole (30 mg BID) (days 1-14) Drug: Amoxicillin 7 days of Amoxicillin (1000 mg BID) (days 1-7) Drug: Clarithromycin 7 days of Clarithromycin (500 mg BID) (days 8-14) Drug: Metronidazole 7 days of Metronidazole (500 mg BID) (days 8-14) |
No Intervention: Controls
75-80 children with H. pylori-persistent infection, who will not receive eradication therapy
|
|
No Intervention: Non infected Controls
60 adolescents with no H. pylori infection, they will not receive eradication therapy
|
- Percentage of persistently-infected teenagers which change UBT status from positive to negative 1 month post-treatment, as compared to non-treated subjects. [ Time Frame: a. Baseline: 2 or 3 samples obtained pre-treatment (separated by 30 days) to detect persistently infected children b. One month post-treatment. ]UBT samples will be obtained pre-treatment and 1 month post-treatment
- Change in the percentage of persistently-infected teenagers of the treatment-arm which have "gastric disease" according to gastroenterologist examination from baseline (pre-treatment) to 2-4 months, as compared to non-treated subjects. [ Time Frame: a. Baseline evaluation during the month prior to treatment. b. 2-4 months post treatment ]Clinical evaluation by gastroenterologist or trained physician, blind to the treatment arm of the subject, for specific GI signs/symptoms, will be performed at baseline (during the month prior to treatment) and posttreatment (2-4 months post treatment).
- Change in blood levels of biomarkers indicative of gastric damage in treated as compared to non-treated subjects after 6 month follow up. [ Time Frame: a. Baseline: Within 2 weeks before initiation of eradication treatment and at similar time-frame in non-treated age matched controls (pre-sample) b. 1 month after treatment c. 6 months post treatment ]Blood samples for Pepsinogen (PG) I, PGII, gastrin and other potential biomarkers of "gastric damage. PGI/PGII/Gastrin-17: will be assessed in serum using GastroPanel® (Biohit Oyj, Helsinki, Finland). Two additional biomarkers of GC will be assessed by ELISA-commercial kits: VCAM-1 and CXCL13. Samples will be collected at baseline, 1 month and 6 months post treatment.
- Change in faecal Escherichia coli and Enterococcus antimicrobial resistance rates in treated subjects from baseline to 1 month and 6-12 months post treatment, as compared to non-treated subjects. [ Time Frame: a. Baseline: Within one month before treatment b. 1 month post treatment c. 6-12 months post treatment (and at similar time-frame in non-treated age matched controls)] ]Phenotypic antimicrobial susceptibility analysis of Escherichia coli and Enterococcus will be performed from stool samples obtained in both Cases and Controls by Kirby Bauer disc diffusion method. According to patterns of AMR of each bacteria, and the antimicrobials used in this trials, E. coli will be tested against clarithromycin, ampicillin, ampicillin-sulbactam, cefazolin, ceftazidime, levofloxacin, and gentamicin; and Enterococcus will be tested against clarithromycin, ampicillin, ampicillin-sulbactam, penicillin, vancomycin and quinopristin/dalfopristin.
- Change in gut microbiome alpha-diversity index in treated subjects from baseline to 1 month and 6-12 months post-treatment, as compared to to non-treated subjects. [ Time Frame: a. Baseline: Within one month before treatment b. 1 month post treatment c. 6-12 months post treatment (and at similar time-frame in non-treated age matched controls)] ]For microbiome analysis 30 stool samples from each group (Cases and controls) will be obtained pre and post treatment. Changes in gut microbiota composition in stool samples will be analyzed by sequencing of the 16S rRNA V3 to V4 hypervariable region using Illumina
- Effect of treatment on frequency of clarithromycin resistance comparing those subject who would not eradicate with non-treated individuals [ Time Frame: a. Baseline: Within 1 month before eradication b.Within 3 months after the positive UBT sample indicating non-eradication or reinfection. ]Stool evaluation for presence of Clarithromycin resistance genes will be performed in stool samples obtained before eradication (30 in each group), and after the positive UBT or SAT sample indicating non-eradication or reinfection in conjunction with testing of a similar number of non-treated UBT or SAT positive subjects (20 in each group, including 10 treated and non-eradicated subjects). From DNA isolated from stools, qPCR for ureC will be performed to confirm H. pylori infection, and then qPCR to 23SrRNA gene mutations by Taqman probes will be performed.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy teenagers 14-18 years of age from Colina, Temuco or Coyhaique
- At least one responsible adult family member accessible for phone contact.
- Persistent H. pylori infection determined by at least 2 positive UBT tests in a 3 months period (except for Non-infected Controls)
Exclusion Criteria:
- Teenagers not consenting to treatment will be invited to continue as non-treated controls.
- Known allergy to any of the antimicrobials used in the trial protocol (except for Non-infected Controls)
- Signs/symptoms compatible with organic abdominal pain according to Rome IV criteria: persistent right upper or right lower quadrant pain, dysphagia, odynophagia, persistent vomiting, gastrointestinal blood loss, involuntary weight loss, deceleration of linear growth, delayed puberty.
- Prior eradication therapy
- Antimicrobial course received during the previous month (at least 3 days of treatment at appropriate dosing, children meeting this criteria can be included at a later stage)
- Pregnancy
- Use of immunosuppressive or biologic drugs
- Known allergy to antimicrobials included in eradication scheme
- Children deemed "not healthy" after review of the questionnaire by study physician
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05926804
Contact: Yalda Lucero, MD, PhD | +56997330860 | ylucero@uchile.cl | |
Contact: Sergio George, MD, PhD | +56225756103 | sgeorge@ug.uchile.cl |
Chile | |
Universidad de Aysén | Recruiting |
Coyhaique, Chile | |
Contact: Beatriz Zabala, PhD +56996503803 beatriz.zabala@uaysen.cl | |
Universidad de Chile | Recruiting |
Santiago, Chile | |
Contact: Sergio George, MD, PhD +56225756103 sgeorge@ug.uchile.cl | |
Universidad de la Frontera | Recruiting |
Temuco, Chile | |
Contact: Lilian Fernández, MD +56984282646 liliufro@gmail.com |
Principal Investigator: | Miguel O'Ryan, MD | University of Chile |
Responsible Party: | Miguel O'Ryan Gallardo, Medical Doctor, Pediatrician, Infectious Diseases Specialist. Full Professor., University of Chile |
ClinicalTrials.gov Identifier: | NCT05926804 |
Other Study ID Numbers: |
1220964 1220964 ( Other Grant/Funding Number: Fondecyt Fondo Nacional de Desarrollo Científico y Tecnológico ) |
First Posted: | July 3, 2023 Key Record Dates |
Last Update Posted: | January 5, 2024 |
Last Verified: | January 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Helicobacter pylori Screen and treat Pepsinogen Adolescent |
Amoxicillin Metronidazole Clarithromycin Lansoprazole Dexlansoprazole Anti-Bacterial Agents Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |