Probiotics in Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus, Maltodextrin (Placebo).
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial
Overview
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
Interventions
- Other Lactobacillus
5 billion CFU of lactobacilus ans streptococci once daily for 60 days - Other Maltodextrin (Placebo)
Placebo capsules will be given one a day for 60 days
Primary outcome measures
- Change in Gastrointestinal Symptom Rating Scale [Time frame: 30 and 60 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07276009 · MS-GIT-FD-A0004