Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02645201
Other study ID # Gastrus01
Secondary ID
Status Withdrawn
Phase N/A
First received December 12, 2015
Last updated August 18, 2017
Start date January 2016
Est. completion date August 18, 2017

Study information

Verified date August 2017
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain.

Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.


Description:

This is a 10 week, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy of GASTRUS® on the frequency of adverse events and eradication rate of H. pylori infection in children.

Subjects: Children aged 5 (>15 kg) -18 years, diagnosed with H. pylori infection during upper endoscopy with at least two validated tests, who meet all inclusion and exclusion criteria listed below. Subjects who are RUT (Rapid Urease Test) positive on the day of endoscopy will be offered to participate in the study, which includes 3 visits. They will be given information about the study and a 1-week diary to be filled out before visit 1. The properly filled diary will be considered as the screening tool to include the patients into the study and will be also considered as part of the study. At visit 1 written informed consent must be obtained from the caregivers and also from participants above 10 years of age. At each visit, physical examination will be performed as well as symptom assessment and diary evaluation. Only patients who have a positive culture for H. pylori and antibiotic susceptibility testing with no double resistance, and have filled in the diary will be enrolled. Patients will receive a prescription for triple therapy: omeprazole, amoxicillin and metronidazole / clarithromycin for 14 days depending on the antibiotic susceptibility. The dose regimens will be determined according to the weight of the child. The children will be randomized to receive chewable tablets containing 4x108 CFU of GASTRUS® or placebo of similar appearance and taste. Active and placebo tablets will be supplied. Subjects will take 1 tablet twice a day for 21 days. Diary 2 - will be dispensed (with instructions) and filled for 21 days until visit 2. Visit 2 will take place 21+/- 3 days after visit 1. At this visit a physical exam will be performed and diary 2 will be collected. Diary 3 will be reminded to be filled out one week before visit 3 which will be planned 8 weeks after visit 2 +/- 5 days. At visit 3, diary 3 will be collected. 13C-urea breath test or monoclonal stool antigen test will be performed to assess the H. pylori status after eradication treatment. In order to ensure that the children will fill their diaries, the parents will be phoned one week before visit 2 and 3.

Our study population will be children from all over Europe and Israel diagnosed with H. pylori infection with at least two recommended diagnostic methods. The investigators will complete documents considered for enrolment.

The sample size was calculated assuming that adverse effects will develop in 30% of treated children, aiming to detect difference of 20% based on a 0.80 power to detect statistically significant difference; therefore the recruitment will continue until 118 subjects are randomized into the 2 groups (test and placebo) of at least 59 children each. The estimated time to finish the study is 2-3 years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 18, 2017
Est. primary completion date August 18, 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

1. Either sex age between 5 (>15 kg) - 18 years.

2. Confirmed H. pylori infection (two out of four invasive methods positive (rapid urease test/histology/culture/PCR test) with positive culture and susceptibility testing for clarithromycin and metronidazole).

3. Able to be informed (patient/parents) of the nature of the study and willing to give written informed consent (consent from the parents must be obtained before any study-related procedures are conducted and assent of the child if older than 10 years).

4. Treatment naive children with H. pylori infection.

Exclusion Criteria:

1. Significant acute or chronic GE disease (IBD, symptomatic coeliac disease…)

2. Known allergies to used antibiotics, proton pump inhibitors or probiotics

3. Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.

4. Having received proton pump inhibitors during the previous two weeks.

5. Having received probiotic therapy during the previous 14 days.

6. Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)

7. Severe acquired or primary immunodeficiency.

8. Children with gastric or duodenal peptic ulcer disease

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Gastrus
to compare Gastrus 4x108 tbl twice a day to placebo tbl
Other:
Placebo
to compare Gastrus 4x108 tbl twice a day to placebo tbl

Locations

Country Name City State
Belgium Queen Fabiola Children's Hospital Brussels
Croatia Children's Hospital Zagreb Zagreb
Germany Dr. von Hauner Children's Hospital Munich
Israel Kaplan Medical Center Rehovot
Slovenia University Children's Hospital Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Countries where clinical trial is conducted

Belgium,  Croatia,  Germany,  Israel,  Slovenia, 

References & Publications (1)

Francavilla R, Polimeno L, Demichina A, Maurogiovanni G, Principi B, Scaccianoce G, Ierardi E, Russo F, Riezzo G, Di Leo A, Cavallo L, Francavilla A, Versalovic J. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, do — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary to compare changes of frequency and type of adverse events (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency) in probiotic and placebo arm at different time frames symptom diary (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency-frequency) at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)
Secondary to compare the number of patients with succesful eradication of Helicobacter pylori infection in probiotic and placebo arm 13C-urea breath test or monoclonal stool antigen test 8-12 weeks after eradication therapy
See also
  Status Clinical Trial Phase
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Recruiting NCT03365609 - A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children N/A
Completed NCT00005496 - Inflammation, Infection, and Future Cardiovascular Risk N/A
Completed NCT01219764 - A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection Phase 4
Completed NCT00216450 - Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults. Phase 4
Completed NCT00212225 - Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori) N/A
Completed NCT00083291 - Helicobacter Pylori and Dry Eye N/A
Not yet recruiting NCT04652284 - Effectiveness of Rifabutin for Treatment of Helicobacter Pylori Phase 3
Completed NCT02449941 - Helicobacter Pylori and Proton Pump Inhibitor N/A
Completed NCT02395458 - Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens Phase 4
Completed NCT00194688 - Breath Ammonia Method for H. Pylori Detection: Phase II Phase 2
Not yet recruiting NCT02126722 - Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy N/A
Active, not recruiting NCT01133951 - Helicobacter Pylori Eradication to Prevent Gastric Cancer N/A
Completed NCT00669955 - Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy Phase 3
Completed NCT00816140 - Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication Phase 4
Completed NCT00490386 - Helicobacter Pylori and Acute Alcohol Induced Pancreatitis N/A
Terminated NCT00664209 - Treating H. Pylori in Parkinson's Patients With Motor Fluctuations Phase 3
Completed NCT01922505 - Eradication Rates of Helicobacter Pylori and Its Affecting Factors Phase 4
Completed NCT01792700 - Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy Phase 4
Completed NCT02970110 - Specimen Collection Study for H. Pylori Testing