Probiotic and ginger supplement for symptoms and quality of life in functional dyspepsia

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

This study will test whether a daily Symbiosys Stomalex supplement (Bacillus coagulans MY01, Bacillus subtilis MY02 and ginger) can reduce symptoms and improve quality of life in adults with functional dyspepsia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biocodex (Industry-sponsored)
• Locations: 1 site (Istres)
• Trial ID: NCT07212907 on ClinicalTrials.gov

What this trial studies

SUBTILE is a prospective, interventional, multicenter trial conducted in France that gives the dietary supplement Symbiosys Stomalex to adults meeting Rome IV criteria for functional dyspepsia. Eligible participants have a normal upper endoscopy, negative Helicobacter pylori test, and a baseline PAGI-SYM total score above 1. The study uses patient diaries and validated questionnaires to track symptom severity, gastric symptom-related quality of life, and tolerability over the treatment period. Safety and adherence will also be monitored by investigators at participating centers.

Who should consider this trial

Good fit: Adults aged 18 or older with functional dyspepsia by Rome IV criteria, normal upper endoscopy and negative H. pylori test, a baseline PAGI-SYM score >1, and the ability to complete study diaries and give informed consent are ideal candidates.

Not a fit: Patients with structural gastrointestinal disease, active Helicobacter pylori infection, other identifiable causes of their symptoms, pregnancy, or contraindications to probiotics or ginger are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the supplement could offer a well-tolerated, non-prescription option to reduce dyspeptic symptoms and improve daily quality of life.

How similar studies have performed: Previous randomized data have shown symptom improvement with Bacillus coagulans MY01 and Bacillus subtilis MY02, and clinical and preclinical evidence supports ginger's benefit for gastric motility, so this approach builds on prior positive findings.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Istres

• Gerard DASSA — Istres, France (Recruiting)

Study contacts

• Principal investigator: Guillaume GOURCEROL, Pr — University Hospital, Rouen
• Study coordinator: Pietro TODESSAYI

Conditions Functional Dyspepsia; Bacillus coagulans MY01; Bacillus subtilis MY02; Ginger extract; Symbiosys Stomalex; Gut microbiota; Quality of life; Gastrointestinal symptoms