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

NCT04473079 | Completed Phase 2

• 1 other identifier: I-020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Efficacy: Frequency and severity of dyspeptic symptoms from baseline

  At week 6 after treatment

• Efficacy: Severity of gastrointestinal symptoms

  At week 6 after treatment

• Efficacy: Health-related quality of life (HR-QoL)

  At week 6 after treatment

• Quantification of adverse events during the intervention

  At week 12 after treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks.

Dietary Supplement: Placebo

Interventions

Lacidofil DIETARY_SUPPLEMENT

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

Experimental group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related 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 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

  RESULT

Study Officials

• Ratha-korn Vilaichone

  Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind trial

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 16, 2020
• Study Start: October 16, 2020
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: April 17, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)