Reflux DiseaseEarly Phase 1NCT07600008
Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
A Early Phase 1 study testing A probiotic dietary supplement in people with Reflux Disease and Microbiome, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Reflux Disease, Microbiome, Probiotics Supplement
- What is being tested?
- A probiotic dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jan 2026to 30 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed GERD.
- Stable health without current complications.
- Patients on stable pharmacological PPI therapy (rabeprazole).
Who cannot join
- Use of probiotics or prebiotics within the last 4 weeks.
- Pregnancy or breastfeeding.
- Systemic antimicrobial therapy within the last 4 weeks.
- Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks.
- Serious chronic disease that could affect study results, including cancer, diabetes, inflammatory bowel disease, diagnosed SIBO.
- Prior surgeries, especially fundoplication and resections of the esophagus or stomach.
- Patients with psychiatric or cognitive disorders.
- Hypersensitivity to components of the investigational product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Vít Navrátil, MUDr, Ph.D., +420588445308, vit.navratil@fnol.cz
About this study
A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux.
The objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms.
Read more
Patients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur.
Oral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.
- Conditions
- Reflux Disease, Microbiome, Probiotics Supplement
- Being tested
- A probiotic dietary supplement, Placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A probiotic dietary supplementDietary supplement
A probiotic dietary supplement containing a blend of probiotic bacteria from the Lactobacillaceae family, and the genera Streptococcus and Bifidobacterium, selected based on the latest knowledge concerning the use of probiotics in relation to GERD.
PlaceboDietary supplement
placebo with the same appearance as the probiotic supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplement | Active comparator | Not described Receives: Dietary Supplement: A probiotic dietary supplement |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of % of patients with dysbiosis in the gastrointestinal tract caused by the disease itself and/or pharmacotherapy - as assessed by using whole-genome sequencing
Measured: From enrollment to the end of supplementation at 6 weeks
Secondary outcomes (2)
Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires
Measured: From enrollment to the end of supplementation at 6 weeks
Evaluation of safety and tolerability of the preparation - prevalence of patient-reported adverse events as recorded in questionnaires
Measured: From enrollment to the end of supplementation at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 Jan 2026
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600008
- Sponsor's protocol ID
- FW10010127
- Status last verified
- May 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
- ClinicalTrials.gov ID
- NCT07600008
- Acronym / sponsor ID
- FW10010127
- Conditions
- Reflux Disease, Microbiome, Probiotics Supplement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 May 2026 (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.
A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux.
The objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms.
Patients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur.
Oral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplement | Active comparator | Dietary Supplement: A probiotic dietary supplement |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed GERD.
- Stable health without current complications.
- Patients on stable pharmacological PPI therapy (rabeprazole).
Key exclusion criteria (8 listed)
- Use of probiotics or prebiotics within the last 4 weeks.
- Pregnancy or breastfeeding.
- Systemic antimicrobial therapy within the last 4 weeks.
- Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks.
- Serious chronic disease that could affect study results, including cancer, diabetes, inflammatory bowel disease, diagnosed SIBO.
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 |
|---|---|---|
| A probiotic dietary supplementA probiotic dietary supplement containing a blend of probiotic bacteria from the Lactobacillaceae family, and the genera Streptococcus and Bifidobacterium, selected based on the latest knowledge concerning the use of probiotics in relation to GERD. | Dietary supplement | Probiotic supplement |
| Placeboplacebo with the same appearance as the probiotic supplement | Dietary supplement | Placebo group |
Primary outcome
Change of % of patients with dysbiosis in the gastrointestinal tract caused by the disease itself and/or pharmacotherapy - as assessed by using whole-genome sequencing
Time frame: From enrollment to the end of supplementation at 6 weeks
2 secondary outcomes
Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires
Time frame: From enrollment to the end of supplementation at 6 weeks
Evaluation of safety and tolerability of the preparation - prevalence of patient-reported adverse events as recorded in questionnaires
Time frame: From enrollment to the end of supplementation at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing A probiotic dietary supplement in people with Reflux Disease and Microbiome, run by University Hospital Olomouc at 1 site in Czechia.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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 Czechia. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vít Navrátil, MUDr, Ph.D. (+420588445308, vit.navratil@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of % of patients with dysbiosis in the gastrointestinal tract caused by the disease itself and/or pharmacotherapy - as assessed by using whole-genome sequencing (time frame: From enrollment to the end of supplementation at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.