Helicobacter Pylori InfectionPhase 2/3NCT04473079
Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia
A Phase 2/3 study testing Lacidofil in people with Helicobacter Pylori Infection, run by Lallemand Health Solutions at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Lacidofil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 16 Oct 2020to 17 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
About this study
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
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lacidofil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacidofilDietary supplement
Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
PlaceboDietary supplement
Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At week 12 after treatment
Secondary outcomes (4)
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
Measured: At week 6 after 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
Measured: At week 6 after 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
Measured: At week 6 after treatment
Quantification of adverse events during the intervention
Quantification of adverse and serious adverse events deemed by PI as related to the probiotic
Measured: At week 12 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Oct 2020
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ratha-korn Vilaichone, Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473079
- Sponsor's protocol ID
- I-020
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiattiweerasak A, Aumpan N, Chonprasertsuk S, Pornthisarn B, Siramolpiwat S, Bhanthumkomol P, Nunanan P, Issariyakulkarn N, Mahachai V, Yamaoka Y, Vilaichone RK. 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. Front Gastroenterol (Lausanne). 2023 Sep 14;2:1245993. doi: 10.3389/fgstr.2023.1245993. eCollection 2023.
PubMed 41821821
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04473079
- Acronym / sponsor ID
- I-020
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: LacidofilThese 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. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThese participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacidofilInvestigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only. | Dietary supplement | Experimental group |
| PlaceboInvestigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only. | Dietary supplement | Placebo group |
Primary outcome
Rate of H. pylori eradication
Time frame: At week 6 after treatment
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
Time frame: At week 12 after treatment
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)
4 secondary outcomes
Efficacy: Frequency and severity of dyspeptic symptoms from baseline
Time frame: At week 6 after treatment
Efficacy: Severity of gastrointestinal symptoms
Time frame: At week 6 after treatment
Efficacy: Health-related quality of life (HR-QoL)
Time frame: At week 6 after treatment
Quantification of adverse events during the intervention
Time frame: At week 12 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 41821821Kiattiweerasak A, Aumpan N, Chonprasertsuk S, Pornthisarn B, Siramolpiwat S, Bhanthumkomol P, Nunanan P, Issariyakulkarn N, Mahachai V, Yamaoka Y, Vilaichone RK. 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. Front Gastroenterol (Lausanne). 2023 Sep 14;2:1245993. doi: 10.3389/fgstr.2023.1245993. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratha-korn Vilaichone principal investigator
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lacidofil in people with Helicobacter Pylori Infection, run by Lallemand Health Solutions at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of H. pylori eradication (time frame: At week 6 after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.