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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012534 |
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Date of registration:
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27/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of a probiotic combination on anti-Helicobacter pylori treatment related adverse effects in children - a multicenter double blind RCT
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Scientific title:
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Effect of a probiotic combination on anti-Helicobacter pylori treatment related adverse effects in children - a multicenter double blind RCT - HeliP Study |
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Date of first enrolment:
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01/04/2018 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting stopped after recruiting started |
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URL:
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http://drks.de/search/en/trial/DRKS00012534 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Germany
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Israel
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Portugal
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Slovenia
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Spain
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Contacts
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Name:
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Sibylle
Koletzko |
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Address:
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Lindwurmstr. 4
80337
München
Germany |
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Telephone:
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+4989440057854 |
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Email:
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Sibylle.Koletzko@med.uni-muenchen.de |
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Affiliation:
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Dr. von Haunersches Kinderspital, Abt. Pädiatrische Gastroenterologie & Hepatologie, Klinikum der Universitaet Muenchen (AöR) |
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Name:
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Thu Giang
Le Thi |
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Address:
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Lindwurmstr. 4
80337
München
Germany |
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Telephone:
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+4989440057854 |
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Email:
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tlethi@med.lmu.de |
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Affiliation:
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Dr. von Haunersches Kinderspital, Abt. Pädiatrische Gastroenterologie & Hepatologie, Klinikum der Universitaet Muenchen (AöR) |
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Key inclusion & exclusion criteria
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Inclusion criteria: (a) Male or female patients aged between 5 - 18 years.
(b) Minimal body weight of 15 kg.
(c) H. pylori infection confirmed by positive culture and results of susceptibility testing for clarithromycin and metronidazole.
(d) No previous therapy for H. pylori infection.
(e) Screening diary completed with = 6/7 days.
(f) Written informed consent by parents/care giver and patients (6-11 years and 12-17 years).
Exclusion criteria: (a) Significant acute or chronic gastrointestinal or other disease interfering with assessment of symptoms.
(b) Known allergies to used antibiotics, proton pump inhibitors or probiotics.
(c) Having received treatment with antibiotics or bismuth compounds during the previous 30 days.
(d) Having received proton pump inhibitors during the previous two weeks.
(e) Having received probiotic therapy during the previous 14 days.
(f) Being infected with a strain resistant to clarithromycin and metronidazole (double resistant).
(g) Severe acquired or primary immunodeficiency.
(h) Diarrhea as defined in the study protocol for at least 2 days documented on the screening diary.
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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B98.0
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Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
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Side effects of H. pylori treatment: diarrhea, constipation, abdominal pain, bloating etc.
B98.0
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Intervention(s)
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Group 1: Intervention group with probiotic tablets 2x a day for 3 weeks (during two weeks of Helicobacter treatment and a week thereafter). Probiotic tablet is a food supplement (not a drug) containing L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475.
Other ingredients are: Bulking agent (isomalt), flavor enhancer (citric acid), Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475, palm oil, mint flavoring and mandarin flavoring. This food supplement is currently freely on sale under the name “Gastrus®” of Biogaia, Sweden.
Group 2: Control group with placebo tablets 2x a day for 3 weeks (during two weeks of Helicobacter treatment and a week thereafter). Placebo tablet is a dummy or pretend tablet. It contains no probiotics, only maltodextrin and mandarin flavoring.
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Primary Outcome(s)
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Incidence of diarrhea during the 3 weeks intervention period defined as percentage of patients developing diarrhea. Diarrhea is defined as increased frequency (>3 stools per day) with loose consistency (equal to Bristol stool scale (BSS) of 5 or 6) or >1 watery stool per day (BSS 7).
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Secondary Outcome(s)
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(1) Incidence of other adverse events (abdominal pain, bloating, nausea, vomiting, bad (metallic) taste during the 3 weeks intervention period.
(2) Duration and severity of diarrhea during the 3 weeks intervention period in days.
(3) Percentage of patients with an intake of drugs from triple therapy less than 80% during the 2 week treatment period.
(4) Percentage of patients with successful H. pylori eradication at follow up at visit 4.
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Secondary ID(s)
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MOH_2019-03-12_006018
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Source(s) of Monetary Support
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Biogaia AB
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Ethics review
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Status: Approved
Approval date: 15/05/2017
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
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