Dyspepsia, Signs and Symptoms, Digestive
Conditions
Keywords
Functional dyspepsia, Abdominal pain, Flatulence, Probiotics, Bifidobacterium, Lactobacillus
Brief summary
The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbiotic mix CBP-004019/C
One capsule per day of the probiotic mix CBP-004019/C during one month.
DIETARY_SUPPLEMENTPlacebo
One capsule per day of the placebo (maltodextrin) during one month.
Sponsors
Hospital Universitario Central de Asturias
National Research Council, Spain
Biopolis S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria
Exclusion criteria
* Celiac disease or other organic GI disease * Orthorexia nervosa or other eating disorders * Special dietary patterns (vegans, vegetarians, macrobiotic, exclusion diets, etc.) * Extreme BMI (\<18,8 or \> 39,9) * Metabolic disorders * Positive Helicobacter pylori test * Congenital IgA deficiency * Lactose malabsorption/intolerance * SIBO * Diabetes * Scleroderma, CREST, lupus or other connective tissue diseases * Previous GI surgery or neoplastic disease * Treatment with non steroidal anti-inflammatory drugs and/or acetyl salicylic acid. * Pregnancy * Menopause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional dyspepsia symptoms | 3 months | Physician determined symptoms according to Rome III criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspepsia associated quality of life | 3 months | Questionaires for symptoms and QoL associated to dyspepsia and for anxiety/depression |
| Serum IFN-gamma levels | 3 months | Determination of the serum concentration (pg/mL) of IFN-gamma |
| Serum TNF-alpha levels | 3 months | Determination of the serum concentration (pg/mL) of TNF-alpha |
| Serum IL-12 levels | 3 months | Determination of the serum concentration (pg/mL) of IL-12 |
| Serum IL-4 levels | 3 months | Determination of the serum concentration (pg/mL) of IL-4 |
| Serum IL-10 levels | 3 months | Determination of the serum concentration (pg/mL) of IL-10 |
| Relative proportions of the main microbial groups of the intestinal microbiota | 3 months | Global profile of intestinal microbiota composition established by 16S rRNA profiling |
| Fecal levels of Bifidobacterium | 3 months | Determination of the levels (log cells/gr) of Bifidobacterium in fecal samples by qPCR |
| Fecal levels of Lactobacillus | 3 months | Determination of the levels (log cells/gr) of Lactobacillus in fecal samples by qPCR |
| Fecal levels of Bacteroides | 3 months | Determination of the levels (log cells/gr) of Bacteroides in fecal samples by qPCR |
| Fecal levels of Blautia | 3 months | Determination of the levels (log cells/gr) of Blautia in fecal samples by qPCR |
| Fecal levels of Akkermansia | 3 months | Determination of the levels (log cells/gr) of Akkermansia in fecal samples by qPCR |
| Fecal levels of Faecalibacterium | 3 months | Determination of the levels (log cells/gr) of Faecalibacterium in fecal samples by qPCR |
| Serum TGF-beta levels | 3 months | Determination of the serum concentration (pg/mL) of TGF-beta |
Countries
Spain
Contacts
Primary ContactEmpar Chenol, PhD
Backup ContactSalvador Genoves, PhD
Outcome results
None listed