Actively Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Led by Biocodex · Updated on 2026-01-07
198
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (male or female) aged 60;18 years
- Diagnosis of functional dyspepsia according to Rome IV criteria with normal upper endoscopy and negative Helicobacter pylori test
- Presence of bothersome postprandial fullness, early satiety, epigastric pain, or burning at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior
- PAGI-SYM total score greater than 1 at baseline
- Ability to comply with study requirements and provide signed informed consent
- Ability to complete patient diary and questionnaires as judged by investigator
- For women of childbearing potential: negative urine pregnancy test before starting study product and agreement to use approved contraception or be menopausal
- Affiliation with a national health insurance or social security system
You will not qualify if you...
- Use of Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics within 2 weeks before baseline
- Allergy or hypersensitivity to any component of the study product
- Contraindications or warnings related to the study product, including use of anticoagulants
- Use of immunosuppressive therapy within the last 3 months
- Use of medications affecting gastrointestinal motility or sensitivity (opioids, GLP-1 analogs, neuroleptics, antiemetics, anticholinergics); stable antidepressants allowed
- Significant diet or physical activity changes within 2 weeks before baseline or expected during study
- Active somatic or psychiatric disorders explaining dyspeptic symptoms, except stable antidepressant use
- Active Helicobacter pylori infection
- Predominant gastroesophageal reflux disease or irritable bowel syndrome symptoms
- Functional diarrhea or constipation as defined by Rome IV criteria
- Abdominal surgery within past year, except appendectomy, cholecystectomy, inguinal hernia repair, or splenectomy
- Pregnant or breastfeeding women
- Under legal guardianship or curatorship
- Participation in another interventional trial or receipt of investigational product within 30 days before baseline
- Any acute or chronic condition interfering with study assessments, including severe hepatic or renal insufficiency, immunodeficiency, or substance abuse
- Any personal condition making full participation unlikely or impossible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gerard DASSA
Istres, France, 13800
Actively Recruiting
Research Team
P
Pietro TODESSAYI
CONTACT
S
Sophie PARENT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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