Side effects of H. pylori treatment: diarrhea, constipation, abdominal pain, bloating etc. B98.0
Conditions
Interventions
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) containin
Sponsors
Klinikum der Universität München, Campus Innenstadt
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Germany, Israel, Portugal, Slovenia, Spain
Contacts
Public ContactThu Giang Le Thi
Dr. von Haunersches Kinderspital, Abt. Pädiatrische Gastroenterologie & Hepatologie, Klinikum der Universitaet Muenchen (AöR)
Outcome results
None listed