HelicobacterPhase 2/3NCT02725138
Efficacy of Probiotics in the Gut Microbiota and H Pylori Density
A Phase 2/3 study testing Probiotic in people with Helicobacter, run by Statistical Center, NTUHCTC at 1 site in Taiwan.
Trial summary
We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to Dec 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial
Who cannot join
- history of gastrectomy and colectomy
- severe underlying illness, such as malignancy, ESRD, liver failure, etc
- allergy to probiotics
- symptomatic patients who need PPI, antibiotics, or other probiotics
- pregnancy and lactating women
- unable to cooperate with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Lactobacillus Acidophilus and Lactobacillus Rhamnosus in the Modification of Gut Microbiota and Reduction of Helicobacter Pylori Bacterial Load- a Double Blind, Placebo Controlled, Randomized Trial
We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.
Read the detailed description
Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.
- Conditions
- Helicobacter
- Being tested
- Probiotic, Placebo
- Keywords
- Helicobacter pylori, probiotic, bacterial density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks
PlaceboOther
Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | subjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | subjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bacterial load of H. pylori
Measured: after 4 weeks of treatment
Secondary outcomes (2)
changes in gut microbiota
Measured: after 4 weeks of treatment
adverse effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionDec 2020
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 HelicobacterStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statistical Center, NTUHCTC
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Sugar Cooperation Company
- Responsible party
- Sponsor-investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
- Investigators
- Jyh-Ming Liou, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725138
- Sponsor's protocol ID
- 201511071RIPA
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2016
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen MJ, Chen CC, Huang YC, Tseng CC, Hsu JT, Lin YF, Fang YJ, Wu MS, Liou JM; Taiwan Gastrointestinal Disease, Helicobacter Consortium. The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. Helicobacter. 2021 Dec;26(6):e12857. doi: 10.1111/hel.12857. Epub 2021 Oct 27.
PubMed 34708471
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lactobacillus Acidophilus and Lactobacillus Rhamnosus in the Modification of Gut Microbiota and Reduction of Helicobacter Pylori Bacterial Load- a Double Blind, Placebo Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT02725138
- Acronym / sponsor ID
- 201511071RIPA
- Conditions
- Helicobacter
- Keywords
- Helicobacter pylori, probiotic, bacterial density
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Statistical Center, NTUHCTCUniversity, hospital or other
- Collaborators
- Taiwan Sugar Cooperation Company
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.
Detailed description
Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probioticsubjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks |
| Placebo | Placebo comparator | Other: Placebosubjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial
Key exclusion criteria (6 listed)
- history of gastrectomy and colectomy
- severe underlying illness, such as malignancy, ESRD, liver failure, etc
- allergy to probiotics
- symptomatic patients who need PPI, antibiotics, or other probiotics
- pregnancy and lactating women
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 |
|---|---|---|
| ProbioticProbiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks | Dietary supplement | Probiotic |
| PlaceboPlacebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks | Other | Placebo |
Primary outcome
Reduction of bacterial load of H. pylori
Time frame: after 4 weeks of treatment
2 secondary outcomes
changes in gut microbiota
Time frame: after 4 weeks of treatment
adverse effects
Time frame: 4 weeks
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 29 Jun 2021.
- Derived from this study: PubMed 34708471Chen MJ, Chen CC, Huang YC, Tseng CC, Hsu JT, Lin YF, Fang YJ, Wu MS, Liou JM; Taiwan Gastrointestinal Disease, Helicobacter Consortium. The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. Helicobacter. 2021 Dec;26(6):e12857. doi: 10.1111/hel.12857. Epub 2021 Oct 27.
- 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.
Jyh-Ming Liou, MD, PhD principal investigator
National Taiwan 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 Probiotic in people with Helicobacter, run by Statistical Center, NTUHCTC at 1 site in Taiwan.
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 1 inclusion and 6 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 29 Jun 2021. 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 Taiwan. 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?
Reduction of bacterial load of H. pylori (time frame: after 4 weeks of treatment). 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 NCT02725138, 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 29 Jun 2021.