Probiotics in Functional Dyspepsia
ConditionFunctional Dyspepsia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNordic Biotic Sp. z o.o.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years
Postprandial fullness
Early satiation
Epigastric pain or burning
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus
Other intervention5 billion CFU of lactobacilus ans streptococci once daily for 60 days
Maltodextrin (Placebo)
Other interventionPlacebo capsules will be given one a day for 60 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Probiotic groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gastrointestinal Symptom Rating Scale
Time frame
30 and 60 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: