An interventional study of Gastrus and Placebo in Helicobacter Infections, sponsored by University Medical Centre Ljubljana. Withdrawn at 5 sites in 5 countries. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
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Exclusion Criteria:
Children in probiotic group will receive chewable tablets containing 4x108 CFU of Gastrus. Subjects will take 1 tablet twice a day for 21 days
Dietary Supplement: Gastrus
Children in placebo group will receive placebo tablets of similar appearance and taste as Gastrus tablets. Subjects will take 1 placebo tablet twice a day for 21 days
Other: Placebo
to compare Gastrus 4x108 tbl twice a day to placebo tbl
Also known as: Lactobacillus reuteri (ATC 55730 and ATCC PTA 6457)
to compare Gastrus 4x108 tbl twice a day to placebo tbl
Also known as: Placebo pills
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)
Time frame: at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)
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
Time frame: 8-12 weeks after eradication therapy
This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana