Probiotics in Functional Dyspepsia (NCT07276009) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Probiotics in Functional Dyspepsia
60 participantsStarted 2026-01-05
Plain-language summary
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:
* Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?
* Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.
Participants will:
* Take one capsule of the probiotic or placebo once daily before meals for 60 days
* Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months
* Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months
* Attend scheduled study visits for checkups and assessments
Who can participate
Age range18 Years – 65 Years
SexALL
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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:
✓. 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