Helicobacter Infections Clinical Trial
Official title:
Effect of a Probiotic Combination (Gastrus®) on Adverse Effects of Therapy and on Eradication Rate of Helicobacter Pylori Infection in Children
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.
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