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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473079
• Other study ID #: I-020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 16, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: February 2023
• Source: Lallemand Health Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Helicobacter Pylori Infection

Intervention

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
Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Lallemand Health Solutions

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 R0

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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