Functional DyspepsiaSUBTILENCT07212907
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
A study testing Symbiosys® Stomalex (commercial name) in people with Functional Dyspepsia, run by Biocodex at 2 sites in France.
Trial summary
Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Symbiosys® Stomalex (commercial name)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Dec 2025to Jan 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (male or female) aged ≥18 years.
- Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normal upper endoscopy including negative Helicobacter pylori test. Rome IV criteria define FD as the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiety, epigastric pain, or epigastric burning, occurring at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior to diagnosis.
- PAGI-SYM total score >1 at baseline.
- Ability to comply with study requirements and provide signed written informed consent before any study-related procedures.
- Ability to complete the patient diary and questionnaires, in the investigator's opinion (sufficient reading and language comprehension).
- For women of childbearing potential : Negative urine pregnancy test immediately before starting study product ; Agreement to use an approved method of contraception for the duration of the study, unless meeting criteria for menopause (≥12 months of spontaneous amenorrhea). Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, including those whose career, lifestyle, or sexual orientation normally precludes heterosexual intercourse.
- Affiliation with a national health insurance or social security system.
Who cannot join
- Use within 2 weeks prior to baseline of treatments that could interfere with study evaluation, including Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics.
- Known allergy or hypersensitivity to any component of the investigational product.
- Contraindication or specific warning related to the investigational product, including use of anticoagulants.
- Use of immunosuppressive therapy within the last 3 months.
- Use of medications affecting gastrointestinal motility or sensitivity, including opioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stable antidepressant therapy allowed.)
- Significant changes in diet or physical activity within 2 weeks prior to baseline or anticipated during the study period.
Show all 16Show fewer
- Active somatic or psychiatric disorder that could explain dyspeptic symptoms (e.g., active cancer, inflammatory disease). Stable use of one antidepressant is allowed for psychiatric indication.
- Active Helicobacter pylori infection.
- Predominant symptoms of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS).
- Functional diarrhea or functional constipation as defined by Rome IV criteria.
- History of abdominal surgery within the past year, except appendectomy, cholecystectomy, inguinal hernia repair, or splenectomy.
- Pregnant or breastfeeding women.
- Individuals under legal guardianship or curatorship.
- Participation in another interventional clinical trial and receipt of an investigational product within 30 days prior to baseline.
- Any acute or chronic medical or psychiatric condition that, in the investigator's judgment, could interfere with study assessments, including but not limited to severe hepatic or renal insufficiency, immunodeficiency, or substance abuse (alcohol or drugs).
- Any personal condition or circumstance that, in the investigator's judgment, would make full participation in the study unlikely or impossible.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie PARENT contact
France2 sites, 2 recruiting
- Recruiting
Gerard DASSA
Istres, 13800
Gerard DASSA, DR, +33442550010
Gerard DASSA, PR
- Recruiting
CHU Rouen
Rouen, Boulevard Gambetta, 76000
Guillaume GOURCEROL, Pr
About this study
Official title: Effect of a Combination of Spore-forming Probiotics (Bacillus Coagulans MY01 and Bacillus Subtilis MY02) and Ginger Extract on Symptoms and Quality of Life in Patients With Functional Dyspepsia
Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use.
The gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms.
Read more
This study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life.
A total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks.
The primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8.
Secondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS).
The study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events.
The trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.
Read the detailed description
Functional dyspepsia (FD) is one of the most common disorders of gut-brain interaction (DGBI), with an estimated prevalence of 7-8% in the general population. It is defined by Rome IV criteria as bothersome postprandial fullness, early satiety, epigastric pain, or burning, persisting for at least 3 months with onset at least 6 months before diagnosis, and without evidence of structural disease. FD is associated with impaired quality of life, psychological distress, and significant health care utilization. Current treatment options, including proton pump inhibitors and prokinetics, have limited efficacy and potential adverse effects when used long term.
Emerging evidence suggests a role of the gastrointestinal microbiota in FD pathophysiology. Alterations in duodenal microbiota, as well as small intestinal bacterial overgrowth (SIBO) promoted by chronic PPI use, have been reported. Probiotics may reduce dyspeptic symptoms, improve gut barrier function, modulate gastric motility, and exert anti-inflammatory effects.
A randomized controlled trial showed that Bacillus coagulans MY01 and Bacillus subtilis MY02 improved FD symptoms compared to placebo, with good safety and tolerability. In parallel, ginger (Zingiber officinale) has a well-documented gastroprotective effect, supported by both preclinical and clinical data, and has been shown to enhance gastric emptying and reduce upper gastrointestinal discomfort.
The present study (SUBTILE, STO-253) is a prospective, multicenter, interventional trial conducted in France, categorized as RIPH2 (research involving human participants at minimal risks and constraints) under French regulations. The study will evaluate the effect of a dietary supplement combining Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols), marketed in France since January 2025 as Symbiosys® Stomalex.
A total of 198 adult patients with FD (Rome IV criteria, normal endoscopy) will be recruited in primary care and gastroenterology practices. After providing informed consent, eligible participants will receive one capsule per day for 8 weeks. The study involves two in-person visits (baseline and Week 8) and one telephone follow-up at Day 28.
The primary endpoint is the change in total PAGI-SYM score from baseline to Week 8.
Secondary endpoints include changes in PAGI-QoL scores, treatment adherence, use of concomitant therapies, evolution of lower gastrointestinal symptoms, global impressions of change from both patients (PGI-C) and physicians (CGI-I), and satisfaction ratings. An exploratory endpoint evaluates psychological impact using the Hospital Anxiety and Depression Scale (HADS). Safety endpoints include frequency and severity of adverse events.
This study will provide additional clinical evidence on the potential role of spore-forming probiotics combined with ginger extract as a complementary non-pharmacological approach to improve digestive symptoms and quality of life in patients with functional dyspepsia.
- Conditions
- Functional Dyspepsia
- Being tested
- Symbiosys® Stomalex (commercial name)
- Keywords
- Functional Dyspepsia, Bacillus coagulans MY01, Bacillus subtilis MY02, Ginger extract, Symbiosys Stomalex, Gut microbiota, Quality of life, Gastrointestinal symptoms, Spore-forming probiotics, Epigastric Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbiosys® Stomalex (commercial name)Dietary supplement
One oral capsule per day for 8 weeks. Each capsule contains Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger root extract (50 mg, titrated to 20% gingerols).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Probiotic and Ginger Supplement | Experimental | Patients with functional dyspepsia will receive one capsule per day of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) for 8 weeks Receives: Dietary Supplement: Symbiosys® Stomalex (commercial name) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PAGI-SYM total score from baseline to Week 8
The Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) is a validated questionnaire assessing severity of upper gastrointestinal symptoms. Total score ranges from 0 (none) to 5 (very severe). A decrease indicates symptom improvement.
Measured: Baseline (Day 0) and Week 8 (Day 56 ± 3 days)
Secondary outcomes (12)
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Scores During Follow-up
The PAGI-SYM (Patient Assessment of Upper Gastrointestinal Symptom Severity Index) is a validated patient-reported questionnaire assessing upper gastrointestinal symptoms. It includes 20 items scored on a 6-point Likert scale from 0 to 5 (0 = none, 5 = very severe). Subscale scores and the total score are calculated as the mean of completed items. Higher scores indicate worse symptom severity. A decrease from baseline reflects clinical improvement.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Patient Assessment of Upper Gastrointestinal Quality of Life (PAGI-QoL) Total Score
The PAGI-QoL (Patient Assessment of Upper Gastrointestinal Quality of Life) is a validated patient-reported questionnaire measuring quality of life in functional dyspepsia. It includes 30 items, each scored on a 6-point Likert scale from 0 to 5. Subscale and total scores are calculated as the mean of completed items. Total score range: 0 (lowest quality of life) to 5 (highest quality of life). Higher scores reflect better quality of life.
Measured: Baseline, Week 4, and Week 8
Patient adherence to study product assessed by patient diary
Adherence will be assessed using a patient diary in which participants record daily intake of the study product. Adherence will be expressed as the proportion of days with documented capsule intake relative to the total number of days.
Measured: Week 4, and Week 8
Use of concomitant medications for dyspeptic symptoms
Proportion of patients using additional treatments for FD.
Measured: 2 months prior to inclusion and during study period (8 weeks)
Evolution of lower gastrointestinal symptoms
Change in presence/absence of symptoms compared to baseline.
Measured: Baseline and Week 8
Patient's Global Impression of Change (PGI-C)
The PGI-C (Patient's Global Impression of Change) is a self-reported 7-point Likert scale evaluating the patient's perception of change in health status since baseline. The scale ranges from 1 to 7, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores (1-3) indicate clinical improvement, 4 indicates stability, and higher scores (5-7) indicate worsening.
Measured: Week 8
Clinical Global Impression of Improvement (CGI-I)
The CGI-I (Clinical Global Impression of Improvement) is a physician-rated 7-point Likert scale assessing global improvement of the patient's condition compared with baseline. The scale ranges from 1 to 7, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores (1-3) indicate improvement, 4 indicates stability, and higher scores (5-7) indicate worsening.
Measured: Week 8
Patient satisfaction with study product
5-point Likert scale (1 = not at all satisfied; 5 = very satisfied).
Measured: Week 8
Physician satisfaction with study product
5-point Likert scale (1 = not at all satisfied; 5 = very satisfied).
Measured: Week 8
Exploratory: Change in Hospital Anxiety and Depression Scale (HADS) score
Evaluates impact on anxiety and depression. Total score ranges 0-21 per domain; higher scores indicate greater severity.
Measured: Baseline and Week 8
Safety and tolerability (Adverse Events)
Number, severity, and relationship of adverse events (AE) and serious adverse events (SAE).
Measured: From consent signature to Week 8 (end of study)
Patient adherence to study product assessed by capsule count
Adherence will be assessed by counting the number of remaining capsules at study visits. Adherence will be expressed as the proportion of capsules taken relative to the number of capsules dispensed.
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start22 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, multicenter interventional study evaluating a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract in patients with functional dyspepsia
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillaume GOURCEROL, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212907
- Sponsor's protocol ID
- SUBTILE - STO 253
- Other IDs
- 2025-A01409-40
- Acronym
- SUBTILE
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combination of Spore-forming Probiotics (Bacillus Coagulans MY01 and Bacillus Subtilis MY02) and Ginger Extract on Symptoms and Quality of Life in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07212907
- Acronym / sponsor ID
- SUBTILE / SUBTILE - STO 253
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Bacillus coagulans MY01, Bacillus subtilis MY02, Ginger extract, Symbiosys Stomalex, Gut microbiota, Quality of life, Gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Oct 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.
Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use.
The gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms.
This study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life.
A total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks.
The primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8.
Secondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS).
The study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events.
The trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.
Detailed description
Functional dyspepsia (FD) is one of the most common disorders of gut-brain interaction (DGBI), with an estimated prevalence of 7-8% in the general population. It is defined by Rome IV criteria as bothersome postprandial fullness, early satiety, epigastric pain, or burning, persisting for at least 3 months with onset at least 6 months before diagnosis, and without evidence of structural disease. FD is associated with impaired quality of life, psychological distress, and significant health care utilization. Current treatment options, including proton pump inhibitors and prokinetics, have limited efficacy and potential adverse effects when used long term.
Emerging evidence suggests a role of the gastrointestinal microbiota in FD pathophysiology. Alterations in duodenal microbiota, as well as small intestinal bacterial overgrowth (SIBO) promoted by chronic PPI use, have been reported. Probiotics may reduce dyspeptic symptoms, improve gut barrier function, modulate gastric motility, and exert anti-inflammatory effects.
A randomized controlled trial showed that Bacillus coagulans MY01 and Bacillus subtilis MY02 improved FD symptoms compared to placebo, with good safety and tolerability. In parallel, ginger (Zingiber officinale) has a well-documented gastroprotective effect, supported by both preclinical and clinical data, and has been shown to enhance gastric emptying and reduce upper gastrointestinal discomfort.
The present study (SUBTILE, STO-253) is a prospective, multicenter, interventional trial conducted in France, categorized as RIPH2 (research involving human participants at minimal risks and constraints) under French regulations. The study will evaluate the effect of a dietary supplement combining Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols), marketed in France since January 2025 as Symbiosys® Stomalex.
A total of 198 adult patients with FD (Rome IV criteria, normal endoscopy) will be recruited in primary care and gastroenterology practices. After providing informed consent, eligible participants will receive one capsule per day for 8 weeks. The study involves two in-person visits (baseline and Week 8) and one telephone follow-up at Day 28.
The primary endpoint is the change in total PAGI-SYM score from baseline to Week 8.
Secondary endpoints include changes in PAGI-QoL scores, treatment adherence, use of concomitant therapies, evolution of lower gastrointestinal symptoms, global impressions of change from both patients (PGI-C) and physicians (CGI-I), and satisfaction ratings. An exploratory endpoint evaluates psychological impact using the Hospital Anxiety and Depression Scale (HADS). Safety endpoints include frequency and severity of adverse events.
This study will provide additional clinical evidence on the potential role of spore-forming probiotics combined with ginger extract as a complementary non-pharmacological approach to improve digestive symptoms and quality of life in patients with functional dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, multicenter interventional study evaluating a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract in patients with functional dyspepsia
| Arm | Type | Receives |
|---|---|---|
| Experimental: Probiotic and Ginger Supplement | Experimental | Dietary Supplement: Symbiosys® Stomalex (commercial name)Patients with functional dyspepsia will receive one capsule per day of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (male or female) aged ≥18 years.
- Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normal upper endoscopy including negative Helicobacter pylori test. Rome IV criteria define FD as the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiety, epigastric pain, or epigastric burning, occurring at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior to diagnosis.
- PAGI-SYM total score >1 at baseline.
- Ability to comply with study requirements and provide signed written informed consent before any study-related procedures.
- Ability to complete the patient diary and questionnaires, in the investigator's opinion (sufficient reading and language comprehension).
Key exclusion criteria (16 listed)
- Use within 2 weeks prior to baseline of treatments that could interfere with study evaluation, including Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics.
- Known allergy or hypersensitivity to any component of the investigational product.
- Contraindication or specific warning related to the investigational product, including use of anticoagulants.
- Use of immunosuppressive therapy within the last 3 months.
- Use of medications affecting gastrointestinal motility or sensitivity, including opioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stable antidepressant therapy allowed.)
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 |
|---|---|---|
| Symbiosys® Stomalex (commercial name)One oral capsule per day for 8 weeks. Each capsule contains Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger root extract (50 mg, titrated to 20% gingerols). | Dietary supplement | Experimental: Probiotic and Ginger Supplement |
Primary outcome
Change in PAGI-SYM total score from baseline to Week 8
Time frame: Baseline (Day 0) and Week 8 (Day 56 ± 3 days)
The Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) is a validated questionnaire assessing severity of upper gastrointestinal symptoms. Total score ranges from 0 (none) to 5 (very severe). A decrease indicates symptom improvement.
12 secondary outcomes
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Scores During Follow-up
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Patient Assessment of Upper Gastrointestinal Quality of Life (PAGI-QoL) Total Score
Time frame: Baseline, Week 4, and Week 8
Patient adherence to study product assessed by patient diary
Time frame: Week 4, and Week 8
Use of concomitant medications for dyspeptic symptoms
Time frame: 2 months prior to inclusion and during study period (8 weeks)
Evolution of lower gastrointestinal symptoms
Time frame: Baseline and Week 8
Patient's Global Impression of Change (PGI-C)
Time frame: Week 8
Clinical Global Impression of Improvement (CGI-I)
Time frame: Week 8
Patient satisfaction with study product
Time frame: Week 8
Physician satisfaction with study product
Time frame: Week 8
Exploratory: Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline and Week 8
Safety and tolerability (Adverse Events)
Time frame: From consent signature to Week 8 (end of study)
Patient adherence to study product assessed by capsule count
Time frame: Week 4 and Week 8
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 2 Nov 2026.
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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.
Sophie PARENT contact
Guillaume GOURCEROL, Pr principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiosys® Stomalex (commercial name) in people with Functional Dyspepsia, run by Biocodex at 2 sites in France.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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?
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 Pietro TODESSAYI (+33 3 44 86 82 28, p.todessayi@biocodex.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PAGI-SYM total score from baseline to Week 8 (time frame: Baseline (Day 0) and Week 8 (Day 56 ± 3 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 2 Nov 2026.