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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Eradication Treatment in Non-ulcer Dyspepsia: A Randomized, Placebo-controlled, Double-blind, Parallel Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Dietary Supplement: Lacidofil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blind trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus probiotic formulation (commercially-available as Lacidofil) for 12 weeks. | Dietary Supplement: Lacidofil<br>* Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.<br>|
| Placebo Comparator: Placebo group<br>These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks. | Dietary Supplement: Placebo<br>* Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | At week 12 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | At week 12 after treatment |