Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocodex
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Symbiosys® Stomalex (commercial name)
Dietary supplementOne 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).
Treatment groups
198 Participants
are divided into 1 treatment groupGroup A: Experimental: Probiotic and Ginger SupplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 0) and Week 8 (Day 56 ± 3 days)Secondary outcomes
1
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.
Time frame
Baseline, Weeks 2, 4, 6, and 82
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.
Time frame
Baseline, Week 4, and Week 83
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.
Time frame
Week 4, and Week 84
Use of concomitant medications for dyspeptic symptoms
Proportion of patients using additional treatments for FD.
Time frame
2 months prior to inclusion and during study period (8 weeks) Source ClinicalTrials.gov