Clinical trial NCT04473079: Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blind trial
Primary purpose: SUPPORTIVE_CARE

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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of H. pylori eradication
timeFrame: At week 6 after treatment
measure: Rate of H. pylori eradication
timeFrame: At week 12 after treatment
Secondary outcomes:
measure: Efficacy: Frequency and severity of dyspeptic symptoms from baseline
timeFrame: At week 6 after treatment
measure: Efficacy: Severity of gastrointestinal symptoms
timeFrame: At week 6 after treatment
measure: Efficacy: Health-related quality of life (HR-QoL)
timeFrame: At week 6 after treatment
measure: Quantification of adverse events during the intervention
timeFrame: At week 12 after treatment
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
Study officials:
affiliation: Thammasat University Hospital
name: Ratha-korn Vilaichone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiattiweerasak A, Aumpan N, Chonprasertsuk S, Pornthisarn B, Siramolpiwat S, Bhanthumkomol P, Nunanan P, Issariyakulkarn N, Mahachai V, Yamaoka Y and Vilaichone R-k. Efficacy and safety of Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 as an adjuvant for Helicobacter pylori eradication: a double-blind, randomized, placebo-controlled study. Frontiers in Gastroenterology 2023; 2:1245993. doi: 10.3389/fgstr.2023.1245993