Functional DyspepsiaProPepsisNCT07276009
Probiotics in Functional Dyspepsia
A study testing Lactobacillus in people with Functional Dyspepsia, run by Nordic Biotic Sp. z o.o. at 1 site in Ukraine.
Trial summary
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are: Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Lactobacillus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Jan 2026to 23 May 2026
- Phase
- Interventional
- 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
- Age 18-65 years
- Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:
- Postprandial fullness
- Early satiation
- Epigastric pain or burning
- (with no evidence of structural disease explaining symptoms)
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- Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
- Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
- Negative for H. pylori (either previously treated successfully or tested negative within study screening)
- Ability and willingness to provide informed consent and comply with study procedures
- Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)
Who cannot join
- Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
- History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
- Positive test for H. pylori during screening (or untreated known infection)
- Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
- Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
- Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap
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- Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence
- Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)
- Pregnancy or lactation, or intention to become pregnant during the study period
- Participation in another clinical trial within the past 3 months
- Known allergy or intolerance to study product components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:
- Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?
- Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.
Read more
Participants will:
- Take one capsule of the probiotic or placebo once daily before meals for 60 days
- Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months
- Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months
- Attend scheduled study visits for checkups and assessments
- Conditions
- Functional Dyspepsia
- Being tested
- Lactobacillus, Maltodextrin (Placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactobacillusOther
5 billion CFU of lactobacilus ans streptococci once daily for 60 days
Maltodextrin (Placebo)Other
Placebo capsules will be given one a day for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | L. rhamnosus LR110, B. lactis BI040, B. breve BB010, L. paracasei LPC100, L. acidophilus LA120, L. casei LR130, L. plantarum LP140, S. thermophilus ST250, B. longum BL020, B. bifidum BF030 5 billion CFU one time daily for 60 days Receives: Other: Lactobacillus |
| Placebo group | Placebo comparator | Product with excepients without probiotic bacteria one time daily for 60 days Receives: Other: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Rating Scale
Measured: 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start15 Jan 2026
- Primary completion1 May 2026
- Study completion23 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276009
- Sponsor's protocol ID
- MS-GIT-FD-A0004
- Acronym
- ProPepsis
- Status last verified
- Sep 2026
- First submitted
- 28 Nov 2025
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial
- ClinicalTrials.gov ID
- NCT07276009
- Acronym / sponsor ID
- ProPepsis / MS-GIT-FD-A0004
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 10 Dec 2025 (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.
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:
- Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?
- Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.
Participants will:
- Take one capsule of the probiotic or placebo once daily before meals for 60 days
- Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months
- Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months
- Attend scheduled study visits for checkups and assessments
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Other: LactobacillusL. rhamnosus LR110, B. lactis BI040, B. breve BB010, L. paracasei LPC100, L. acidophilus LA120, L. casei LR130, L. plantarum LP140, S. thermophilus ST250, B. longum BL020, B. bifidum BF030 5 billion CFU one time daily for 60 days |
| Placebo group | Placebo comparator | Other: Maltodextrin (Placebo)Product with excepients without probiotic bacteria one time daily for 60 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65 years
- Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:
- Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
- Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
- Negative for H. pylori (either previously treated successfully or tested negative within study screening)
Key exclusion criteria (11 listed)
- Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
- History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
- Positive test for H. pylori during screening (or untreated known infection)
- Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
- Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
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 |
|---|---|---|
| Lactobacillus5 billion CFU of lactobacilus ans streptococci once daily for 60 days | Other | Probiotic group |
| Maltodextrin (Placebo)Placebo capsules will be given one a day for 60 days | Other | Placebo group |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale
Time frame: 30 and 60 days
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 25 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus in people with Functional Dyspepsia, run by Nordic Biotic Sp. z o.o. at 1 site in Ukraine.
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 11 inclusion and 11 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 25 Sep 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 Ukraine. 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.
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?
Change in Gastrointestinal Symptom Rating Scale (time frame: 30 and 60 days). 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 25 Sep 2026.