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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: Lacidofil; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Pathumthani
    • Khlong Luang, Pathumthani, Thailand, 12120
      • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
Placebo Comparator: Placebo group; These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks.	Dietary supplement: Placebo; Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Investigators: Principal Investigator: Ratha-korn Vilaichone, Thammasat University Hospital

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: I-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No