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

Primary Purpose

Helicobacter Pylori Infection

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Lacidofil

Placebo

About this trial

This is an interventional supportive care trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Thammasat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Rate of H. pylori eradication

Secondary Outcome Measures

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

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

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

Quantification of adverse events during the intervention

Quantification of adverse and serious adverse events deemed by PI as related to the probiotic

Full Information

NCT ID

NCT04473079

First Posted

July 9, 2020

Last Updated

February 1, 2023

Sponsor

Lallemand Health Solutions

1. Study Identification

Unique Protocol Identification Number

NCT04473079

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

October 16, 2020 (Actual)

Primary Completion Date

June 17, 2022 (Actual)

Study Completion Date

June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lallemand Health Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized, placebo-controlled, double-blind trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lacidofil

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of H. pylori eradication

Description

Time Frame

At week 6 after treatment

Title

Rate of H. pylori eradication

Description

Time Frame

At week 12 after treatment

Secondary Outcome Measure Information:

Title

Efficacy: Frequency and severity of dyspeptic symptoms from baseline

Description

Evaluated by the administration of the Severity of Dyspepsia Assessment (SODA; ranges differ at all three scales) at the end of eradication treatment

Time Frame

At week 6 after treatment

Title

Efficacy: Severity of gastrointestinal symptoms

Description

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

Time Frame

At week 6 after treatment

Title

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

Description

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

Time Frame

At week 6 after treatment

Title

Quantification of adverse events during the intervention

Description

Quantification of adverse and serious adverse events deemed by PI as related to the probiotic

Time Frame

At week 12 after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ratha-korn Vilaichone

Organizational Affiliation

Thammasat University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thammasat University Hospital

City

Khlong Luang

State/Province

Pathumthani

ZIP/Postal Code

12120

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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