Clinical Trial: The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Effect of a Probiotic Combination (Gastrus®) on Adverse Effects of Therapy and on Eradication Rate of Helicobacter Pylori Infection in Children
Brief 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.
Detailed Summary:
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
Sponsor: University Medical Centre Ljubljana
Current Primary Outcome: 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 [ Time Frame: at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: to compare the number of patients with succesful eradication of Helicobacter pylori infection in probiotic and placebo arm [ Time Frame: 8-12 weeks after eradication therapy ]
Original Secondary Outcome: Same as current
Information By: University Medical Centre Ljubljana
Dates:
Date Received: December 12, 2015
Date Started: January 2016
Date Completion: January 2019
Last Updated: December 30, 2015
Last Verified: December 2015
