Probiotics in Functional 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

Qualifiers

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

Treatments tested in this trial

  • Lactobacillus
  • Maltodextrin (Placebo)

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators