<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04473079</url>
  </required_header>
  <id_info>
    <org_study_id>I-020</org_study_id>
    <nct_id>NCT04473079</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lallemand Health Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lallemand Health Solutions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its&#xD;
      efficiency (lower capability to eradicate the infection) due to increasing antibiotic&#xD;
      resistance in the population. But the addition of probiotics to the treatment has been&#xD;
      observed to increase efficiency, and decreasing the antibiotics' side effects. We set to&#xD;
      evaluate whether Lacidofil® STRONG improves efficacy when added to the standard therapy to&#xD;
      eradicate H. pylori.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims at evaluating the efficacy of Lacidofil® STRONG as an adjuvant therapy to a&#xD;
      standard 14-day H. pylori eradication treatment among H. pylori-positive participants with&#xD;
      non-ulcer dyspepsia.&#xD;
&#xD;
      This is a randomized, placebo-controlled trial, with two parallel arms. Participants will be&#xD;
      randomized to receive probiotic or placebo as adjuvant to the standard anti-H. pylori&#xD;
      treatment. Each participant will be enrolled in the study for 12 weeks, during which they&#xD;
      will receive the anti-H. pylori treatment and co-administration of investigational product&#xD;
      (IP; for two weeks), followed by IP supplementation alone (for four weeks), and they will be&#xD;
      followed-up 4 weeks after last IP administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2020</start_date>
  <completion_date type="Actual">June 17, 2022</completion_date>
  <primary_completion_date type="Actual">June 17, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, placebo-controlled, double-blind trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of H. pylori eradication</measure>
    <time_frame>At week 6 after treatment</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of H. pylori eradication</measure>
    <time_frame>At week 12 after treatment</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Frequency and severity of dyspeptic symptoms from baseline</measure>
    <time_frame>At week 6 after treatment</time_frame>
    <description>Evaluated by the administration of the Severity of Dyspepsia Assessment (SODA; ranges differ at all three scales) at the end of eradication treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Severity of gastrointestinal symptoms</measure>
    <time_frame>At week 6 after treatment</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Health-related quality of life (HR-QoL)</measure>
    <time_frame>At week 6 after treatment</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of adverse events during the intervention</measure>
    <time_frame>At week 12 after treatment</time_frame>
    <description>Quantification of adverse and serious adverse events deemed by PI as related to the probiotic</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lacidofil</intervention_name>
    <description>Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thai patients consulting for dyspeptic symptoms.&#xD;
&#xD;
          -  Aged between 18 and 65 years.&#xD;
&#xD;
          -  Diagnosed for H. pylori infection using RUT and 13C-UBT.&#xD;
&#xD;
          -  H. pylori treatment naïve.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Willing to maintain their usual physical activity regime and diet, as well as&#xD;
             discontinuing the consumption probiotic-containing and fermented foods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper gastrointestinal bleeding.&#xD;
&#xD;
          -  Presence of duodenal or gastric ulcers, MALT lymphoma, gastric resection, gastric&#xD;
             malignancy as per endoscopy (visual assessment).&#xD;
&#xD;
          -  Current intake of antibiotics, such as amoxicillin, clarithromycin, metronidazole or&#xD;
             fluoroquinolone.&#xD;
&#xD;
          -  Use of probiotics in the past month, and unwilling to undergo a 2-week washout period&#xD;
             before the study.&#xD;
&#xD;
          -  Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional&#xD;
             use) or 3 weeks (for chronic use) of inclusion.&#xD;
&#xD;
          -  Contraindication for gastric biopsy (e.g., coagulopathy).&#xD;
&#xD;
          -  Any history of allergy for penicillin, levofloxacin, clarithromycin or rabeprazole.&#xD;
&#xD;
          -  Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth&#xD;
             within 2 weeks of trial initiation.&#xD;
&#xD;
          -  Being pregnant or breastfeeding.&#xD;
&#xD;
          -  Having severe underlying disease including end-stage renal disease requiring&#xD;
             hemodialysis or peritoneal dialysis (GFR &lt; 15), cirrhosis with Child-Pugh&#xD;
             classification grade C, immuno-compromised host with AIDS, malignancy and/or&#xD;
             cerebrovascular or cardiovascular disease.&#xD;
&#xD;
          -  Taking anticoagulants (e.g., warfarin) or anti-platelet agents (e.g., clopidogrel)&#xD;
&#xD;
          -  Previous gastric surgery.&#xD;
&#xD;
          -  Having underlying heart disease, including congenital long QT syndrome.&#xD;
&#xD;
          -  Unwilling to stop taking over-the-counter, natural or herbal medicines for dyspeptic&#xD;
             or gastrointestinal symptoms (e.g., antidiarrheal, anti-emetics, antacids) during the&#xD;
             intervention period (6 weeks).&#xD;
&#xD;
          -  Milk and soy allergy.&#xD;
&#xD;
          -  Lactose intolerance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ratha-korn Vilaichone</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thammasat University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thammasat University Hospital</name>
      <address>
        <city>Khlong Luang</city>
        <state>Pathumthani</state>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473079
org study id: I-020
nct id: NCT04473079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, placebo-controlled, double-blind trial
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rate of H. pylori eradication
time frame: At week 6 after treatment
description: 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)
measure: Rate of H. pylori eradication
time frame: At week 12 after treatment
description: 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)
measure: Efficacy: Frequency and severity of dyspeptic symptoms from baseline
time frame: At week 6 after treatment
description: Evaluated by the administration of the Severity of Dyspepsia Assessment (SODA; ranges differ at all three scales) at the end of eradication treatment
measure: Efficacy: Severity of gastrointestinal symptoms
time frame: At week 6 after treatment
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
measure: Efficacy: Health-related quality of life (HR-QoL)
time frame: At week 6 after treatment
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
measure: Quantification of adverse events during the intervention
time frame: At week 12 after treatment
description: Quantification of adverse and serious adverse events deemed by PI as related to the probiotic
arm group label: Experimental group
arm group type: Experimental
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 group label: Placebo group
arm group type: Placebo Comparator
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: Lacidofil
description: Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
arm group label: Experimental group
intervention type: Dietary Supplement
intervention name: Placebo
description: Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ratha-korn Vilaichone
role: Principal Investigator
affiliation: Thammasat University Hospital
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Dyspepsia
sharing ipd: No