Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)

Inclusion Criteria:

• Adults (male or female) aged ≥18 years.

• Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normalupper endoscopy including negative Helicobacter pylori test. Rome IV criteria defineFD as the presence of one or more of the following symptoms: bothersome postprandialfullness, 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 priorto diagnosis.

• PAGI-SYM total score >1 at baseline.

• Ability to comply with study requirements and provide signed written informedconsent before any study-related procedures.

• Ability to complete the patient diary and questionnaires, in the investigator'sopinion (sufficient reading and language comprehension).

• For women of childbearing potential : Negative urine pregnancy test immediatelybefore starting study product ; Agreement to use an approved method of contraceptionfor the duration of the study, unless meeting criteria for menopause (≥12 months ofspontaneous amenorrhea). Women of childbearing potential are defined as all womenphysiologically 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 studyevaluation, 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, includingopioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stableantidepressant therapy allowed.)

• Significant changes in diet or physical activity within 2 weeks prior to baseline oranticipated 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 allowedfor psychiatric indication.

• Active Helicobacter pylori infection.

• Predominant symptoms of gastroesophageal reflux disease (GERD) or irritable bowelsyndrome (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 aninvestigational product within 30 days prior to baseline.

• Any acute or chronic medical or psychiatric condition that, in the investigator'sjudgment, could interfere with study assessments, including but not limited tosevere hepatic or renal insufficiency, immunodeficiency, or substance abuse (alcoholor drugs).

• Any personal condition or circumstance that, in the investigator's judgment, wouldmake full participation in the study unlikely or impossible.