Clinical Trials Logo

Clinical Trial Summary

To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can eradicate H. pylori in humans in the absence of antibiotics.


Clinical Trial Description

Fifty-six (56) subjects, aged 18-70 years will be recruited from patients with dyspeptic symptoms referred to the clinic for consultation about H. pylori infection and who have not previously been treated for this infection. Patients in whom H. pylori infection is confirmed (by endoscopy with biopsy) and who fulfil the inclusion criteria, will be invited to enter the study. After written consent has been obtained subjects will be randomly allocated to one of two groups, one to receive omeprazole (2x20mg/day) + 1 tablet placebo per day and the other to receive omeprazole (2x20mg/day) + 1 tablet (2x108 CFU L. reuteri) ProGastria per day.

After randomisation on Day 0 of the study, the subjects will also be asked to complete a gastrointestinal symptom rating score (GSRS) to determine baseline symptomology.

Intervention will begin on Day 1 and last for 28 days after which therapy will be stopped. The subjects will be asked to complete the GSRS questionnaire on Day 14 and Day 28. At Day 14, the patients GSRS scores are monitored and the patients interviewed. In those patients where there is a marked deterioration of their condition or symptoms, these will be considered treatment failures and eradication therapy will then be started on Day 15.

The day after therapy is stopped (Day 29), patients symptoms will be assessed. All patients will undergo gastroscopy to determine the presence of H. pylori or not. If H. pylori infection is confirmed (by endoscopy and biopsy staining), these subjects will be given triple therapy to eradicate the infection and followed up on Day 90 of the study.

On Day 29, those patients that no longer complain of symptoms and are shown to be free of H. pylori infection by endoscopy (treatment success group), will continue with no further therapy until Day 90.

On Day 90 all subjects will be given a UBT to determine the presence of H. pylori infection and symptoms will be again assessed using GSRS. Asymptomatic patients with negative breath test will be considered recovered. In those patients where persistent H. pylori infection is confirmed by breath test, second line therapy will be implemented as indicated. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01449500
Study type Interventional
Source Lama Medical Care s.r.o.
Contact Ladislav Kuzela, MD
Phone +42 1257 108 511
Email kuzela@thalion.sk
Status Not yet recruiting
Phase N/A
Start date October 2011
Completion date April 2012

See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Completed NCT04429802 - The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Recruiting NCT00978159 - Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia Phase 4
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Terminated NCT00220844 - Tricyclic Antidepressants (TCAs) on Gastric Emptying N/A
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Completed NCT00110968 - Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia Phase 3
Completed NCT00232102 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00164996 - Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia Phase 3
Completed NCT00232037 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Recruiting NCT05718960 - Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia N/A
Completed NCT05750641 - The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Completed NCT04697641 - Helicobacter Pylori Eradication in Functional Dyspepsia N/A
Completed NCT03252743 - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study. N/A
Recruiting NCT04918329 - Functional Digestive Disorders Observatory