Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia

This study aims at evaluating the efficacy of Lacidofil® STRONG as an adjuvant therapy to a standard 14-day H. pylori eradication treatment among H. pylori-positive participants with non-ulcer dyspepsia.

This is a randomized, placebo-controlled trial, with two parallel arms. Participants will be randomized to receive probiotic or placebo as adjuvant to the standard anti-H. pylori treatment. Each participant will be enrolled in the study for 12 weeks, during which they will receive the anti-H. pylori treatment and co-administration of investigational product (IP; for two weeks), followed by IP supplementation alone (for four weeks), and they will be followed-up 4 weeks after last IP administration.

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

• 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.