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

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    100
  • sponsor
    Lallemand Health Solutions
Updated on 6 September 2021
antibiotic therapy
antibiotics
dyspepsia

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 population. But the addition of probiotics to the treatment has been observed to increase efficiency, and decreasing the antibiotics' side effects. We set to evaluate whether Lacidofil STRONG improves efficacy when added to the standard therapy to eradicate H. pylori.

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 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.

Details
Condition H. Pylori Infection, Helicobacter Pylori Infection
Treatment Placebo, Lacidofil
Clinical Study IdentifierNCT04473079
SponsorLallemand Health Solutions
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

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 nave
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
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