Probiotics in Functional Dyspepsia

Inclusion criteria

• Age 18-65 years
• Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:

• Postprandial fullness
• Early satiation
• Epigastric pain or burning
• (with no evidence of structural disease explaining symptoms)
• Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
• Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
• Negative for H. pylori (either previously treated successfully or tested negative within study screening)
• Ability and willingness to provide informed consent and comply with study procedures
• Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)

Exclusion criteria

• Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
• History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
• Positive test for H. pylori during screening (or untreated known infection)
• Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
• Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
• Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap
• Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence
• Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)
• Pregnancy or lactation, or intention to become pregnant during the study period
• Participation in another clinical trial within the past 3 months
• Known allergy or intolerance to study product components