Helicobacter pylori infection H. pylori infection Probiotics
Conditions
Interventions
Participants will receive standard treatment for H. pylori eradication (proton-
pump inhibitor) plus probiotic formulation for 6 weeks.,Participants will receive standard treatment for H. pylori eradication (proton-
pump inhibitor) plus placebo for 6 weeks.
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Experimental group,Placebo group
Sponsors
Lallemand Health Solutions
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Thai patients consulting for dyspeptic symptoms. - Aged between 18 and 65 years. - Diagnosed for H. pylori infection using RUT and 13C-UBT. - H. pylori treatment naïve. - Able to provide informed consent. - Willing to maintain their usual physical activity regime and diet, as well as discontinuing the consumption probiotic-containing and fermented foods.
Exclusion criteria
Exclusion criteria: - Upper gastrointestinal bleeding. - Presence of duodenal or gastric ulcers, MALT lymphoma, gastric resection, gastric malignancy as per endoscopy (visual assessment). - Current intake of antibiotics, such as amoxicillin, clarithromycin, metronidazole or fluoroquinolone. - Use of probiotics in the past month, and unwilling to undergo a 2-week washout period before the study. - Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion. - Contraindication for gastric biopsy (e.g., coagulopathy). - Any history of allergy for penicillin, levofloxacin, clarithromycin or rabeprazole. - Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks of trial initiation. - Being pregnant or breastfeeding. - Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immuno-compromised host with AIDS, malignancy and/or cerebrovascular or cardiovascular disease. - Taking anticoagulants (e.g., warfarin) or anti-platelet agents (e.g., clopidogrel) - Previous gastric surgery. - Having underlying heart disease, including congenital long QT syndrome. - Unwilling to stop taking over-the-counter, natural or herbal medicines for dyspeptic or gastrointestinal symptoms (e.g., antidiarrheal, anti-emetics, antacids) during the intervention period (6 weeks). - Milk and soy allergy. - Lactose intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of H. pylori eradication At 6 and 12 weeks after beginning of intervention Proportion of participants reaching H. pylori eradication as per urea breath test | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of dyspeptic symptoms from baseline At the end of eradication treatment Administration of questionnaire, Severity of Dyspepsia Assessment,Severity of gastrointestinal symptoms At the end of eradication treatment Administration of questionnaire, Gastrointestinal Symptoms Rating Scale,Health-related quality of life At the end of eradication treatment Administration of questionnaire, 36-Item Short Form Survey Instrument (SF-36),Safety of co-administration of probiotics during H. pylori eradication treatment At the end of the study Quantification of AEs and SAEs deemed as related to probiotic by the PI | — |
Countries
Thailand
Contacts
Public ContactRatha-korn Vilaichone
Thammasat University Hospital
Outcome results
None listed