Eradication of Helicobacter Pylori With a Lactobacillus Reuteri Strain Plus Proton Pump Inhibitor

NCT03404440 | Completed

• 1 other identifier: LRHPPPI
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Meta-analyses involving \>4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy in populations with antibiotic resistance have reported a mean increase in eradication rate of 12.2%. It is unclear how to translate that result into clinical practice. To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections. This was a double-blind placebo-controlled randomized 2 site study of L. reuteri (2 x 108 CFU L. reuteri DSM 17938 plus 2 x 108 CFU L. reuteri ATCC PTA 6475) 7 times per day or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size was based on obtaining \>50% cures to be clinically useful as monotherapy.

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter pylori; L. Reuteri; Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• Eradication

  number of patients with H. pylori infection eradicated at 9 weeks assessed by Δ-13C-UBT \<5‰

  Four weeks after post treatmetn assessed by Δ-13C-UBT

Study Arms (2)

L.Reuteri

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 one tablet by mouth 7 times per day + Pantoprazole 20 mg twice a day for 28 days

Other: L.Reuteri

Placebo

PLACEBO COMPARATOR

Placebo one tablet by mouth 7 times per day + Pantoprazole 20 mg twice a day for 28 days

Other: L.Reuteri

Interventions

L.Reuteri OTHER

Also known as: Gastrus

L.Reuteri; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for upper endoscopy for any reason
• Biopsy specimens indicative of Hp infection
• C-UBT indicative of Hp infection
• \> 18 years of age
• Informed consent obtained

You may not qualify if:

• Severe gastritis
• Peptic ulcer
• Pregnancy or lactation
• Malignancy
• Other clinically significant condition
• Alcohol abuse
• Drug abuse
• Patients taking bismuth compounds, anti-secretory drugs, antibiotics or probiotics during 4 weeks preceding endoscopy

Sponsors & Collaborators

• University of Bari: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Clinica Pediatrica

Bari, Apulia, 70125, Italy

Location

Related Publications (2)

• Bibbo S, Ahlstrom G, Pes GM, Graham DY, Engstrand L, Merola E, Dore MP. Resilience of the Gut Microbiome to Short Proton Pump Inhibitor Therapy With or Without High-Dosage L. reuteri in H. pylori-Infected Adults. Helicobacter. 2025 Sep-Oct;30(5):e70064. doi: 10.1111/hel.70064.

  PMID: 40993967 DERIVED

• Dore MP, Bibbo S, Pes GM, Francavilla R, Graham DY. Role of Probiotics in Helicobacter pylori Eradication: Lessons from a Study of Lactobacillus reuteri Strains DSM 17938 and ATCC PTA 6475 (Gastrus(R)) and a Proton-Pump Inhibitor. Can J Infect Dis Med Microbiol. 2019 Apr 1;2019:3409820. doi: 10.1155/2019/3409820. eCollection 2019.

  PMID: 31065301 DERIVED

Study Officials

• ruggiero francavilla, Md PhD

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo capsules were identical in shape, colour and taste to Gastrus capsules but without L. reuteri
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: double-blind randomized, parallel-group, placebo-controlled study.

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 19, 2018
• Study Start: January 15, 2016
• Primary Completion: June 30, 2017
• Study Completion: November 1, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)