Dyspepsia Clinical Trial
Official title:
Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal
The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.
Sixty volunteers with functional GI disorders (Functional dyspepsia according to Rome-III criteria) will be recruited for a randomised, double-blind, placebo-controlled, two-arm parallel study in which the effect upon the gastrointestinal function of a probiotic mix containing bifidobacteria and lactobacilli (manufactured by Biopolis SL) will be compared with placebo (maltodextrin). The study design includes a 4 week run-in period, in which the volunteers will not consume any probiotics/prebiotics, followed by a 4 weeks intervention period (a daily capsule of placebo or probiotic) and an 8 weeks washout period. At the beginning/end of each period questionnaires in gastrointestinal function, dyspepsia related symptoms and diet will be carried out. A serum sample will be taken for cytokine levels determination. A faecal sample will be taken for 16S microbial population profiling and for determining the faecal levels of Bifidobacterium, Bacteriodes, Faecalibacterium, Akkermansia, Lactobacillus and Blautia by qPCR and the concentration of the main bacterial metabolites; acetate, propionate and butyrate by gas-chromatography. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06094062 -
Smartphone App-assisted PPI
|
N/A | |
| Completed |
NCT03941288 -
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
|
Phase 2 | |
| Completed |
NCT04429802 -
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
|
N/A | |
| Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
| Withdrawn |
NCT02863822 -
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
|
N/A | |
| Recruiting |
NCT00978159 -
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
|
Phase 4 | |
| Completed |
NCT00723502 -
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
|
Phase 2 | |
| Completed |
NCT00217347 -
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy
|
N/A | |
| Completed |
NCT00148603 -
Montelukast in the Treatment of Duodenal Eosinophilia
|
N/A | |
| Terminated |
NCT00220844 -
Tricyclic Antidepressants (TCAs) on Gastric Emptying
|
N/A | |
| Completed |
NCT00232102 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
| Completed |
NCT00232037 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
| Completed |
NCT00164996 -
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
|
Phase 3 | |
| Completed |
NCT00110968 -
Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
|
Phase 3 | |
| Recruiting |
NCT05718960 -
Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
|
N/A | |
| Terminated |
NCT04247100 -
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
|
N/A | |
| Completed |
NCT05750641 -
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
|
||
| Completed |
NCT03252743 -
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
|
N/A | |
| Completed |
NCT04697641 -
Helicobacter Pylori Eradication in Functional Dyspepsia
|
N/A | |
| Recruiting |
NCT04918329 -
Functional Digestive Disorders Observatory
|