Status:
RECRUITING
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Lead Sponsor:
Biocodex
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 struct...
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 both...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT07212907
Start Date
December 22 2025
End Date
January 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Gerard DASSA
Istres, France, 13800