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

Last updated: April 15, 2024
Sponsor: Lallemand Health Solutions
Overall Status: Completed

Phase

2/3

Condition

Heartburn

Colic

Bowel Dysfunction

Treatment

Placebo

Lacidofil

Clinical Study ID

NCT04473079
I-020
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 asdiscontinuing the consumption probiotic-containing and fermented foods.

Exclusion

Exclusion Criteria:

  • Upper gastrointestinal bleeding.
  • Presence of duodenal or gastric ulcers, MALT lymphoma, gastric resection, gastricmalignancy as per endoscopy (visual assessment).
  • Current intake of antibiotics, such as amoxicillin, clarithromycin, metronidazole orfluoroquinolone.
  • Use of probiotics in the past month, and unwilling to undergo a 2-week washout periodbefore the study.
  • Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasionaluse) 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 bismuthwithin 2 weeks of trial initiation.
  • Being pregnant or breastfeeding.
  • Having severe underlying disease including end-stage renal disease requiringhemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pughclassification grade C, immuno-compromised host with AIDS, malignancy and/orcerebrovascular 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 dyspepticor gastrointestinal symptoms (e.g., antidiarrheal, anti-emetics, antacids) during theintervention period (6 weeks).
  • Milk and soy allergy.
  • Lactose intolerance.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
October 16, 2020
Estimated Completion Date:
June 17, 2022

Study 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.

Connect with a study center

  • Thammasat University Hospital

    Khlong Luang, Pathumthani 12120
    Thailand

    Site Not Available

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