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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
90
Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
Rate of H. pylori eradication
Efficacy of the H. pylori eradication treatment supplemented with Lacidofil will be done by calculating the proportion of participants reaching H. pylori eradication in probiotics group compared to placebo, as per urea breath test (13C-UBT)
Time frame: At week 6 after treatment
Rate of H. pylori eradication
Efficacy of the H. pylori eradication treatment supplemented with Lacidofil will be done by calculating the proportion of participants reaching H. pylori eradication in probiotics group compared to placebo, as per urea breath test (13C-UBT)
Time frame: At week 12 after treatment
Efficacy: Frequency and severity of dyspeptic symptoms from baseline
Evaluated by the administration of the Severity of Dyspepsia Assessment (SODA; ranges differ at all three scales) at the end of eradication treatment
Time frame: At week 6 after treatment
Efficacy: Severity of gastrointestinal symptoms
Evaluated by the administration of the Gastrointestinal Symptoms Rating Scale (GSRS; overall score range 0 - No discomfort to 105 - Very severe discomfort) at the end of eradication treatment
Time frame: At week 6 after treatment
Efficacy: Health-related quality of life (HR-QoL)
Evaluated by the administration of the 36-Item Short Form Survey Instrument (SF-36; score ranges 0 - worst possible health to 100 - best possible health) at the end of eradication treatment
Time frame: At week 6 after treatment
Quantification of adverse events during the intervention
Quantification of adverse and serious adverse events deemed by PI as related to the probiotic
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Time frame: At week 12 after treatment