Status:
COMPLETED
Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia
Lead Sponsor:
Lallemand Health Solutions
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its efficiency (lower capability to eradicate the infection) due to increasing antibiotic resistance in the popula...
Detailed Description
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 dyspeps...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04473079
Start Date
October 16 2020
End Date
June 17 2022
Last Update
April 17 2024
Active Locations (1)
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1
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand, 12120