Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.

Detailed Description
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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.

Official Title
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Evaluación Del Efecto Del Suplemento Nutricional probiótico Biopolis Sobre la función Gastrointestinal

Conditions
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Signs and Symptoms, Digestive, Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Probiotic mix CBP-004019/C
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test product<br>The volunteers, that have been randomly assigned to the Test product arm of the study, will be administered one oral capsule/day of the Probiotic mix CBP-004019/C (Biopolis SL) during the intervention period (1 month). The product contains 1X10Exp9 cfu/capsule of the probiotic mix (Bifidobacterium lactis, Bifidobacterium longum, Lactobacilus casei and Lactobacillus rhamnosus) plus maltodextrin and sugar. | Dietary Supplement: Probiotic mix CBP-004019/C<br>* One capsule per day of the probiotic mix CBP-004019/C during one month.<br>|
| Placebo Comparator: Placebo product<br>The volunteers that have been randomly assigned to this arm of the study will receive one oral capsule per day of the placebo product (Biopolis SL) during the 1 month intervention period. The product contains maltodextrin and sugar. | Dietary Supplement: Placebo<br>* One capsule per day of the placebo (maltodextrin) during one month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional dyspepsia symptoms | Physician determined symptoms according to Rome III criteria. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative proportions of the main microbial groups of the intestinal microbiota | Global profile of intestinal microbiota composition established by 16S rRNA profiling | 3 months | 
| Dyspepsia associated quality of life | Questionaires for symptoms and QoL associated to dyspepsia and for anxiety/depression | 3 months | 
| Serum IFN-gamma levels | Determination of the serum concentration (pg/mL) of IFN-gamma | 3 months | 
| Serum TNF-alpha levels | Determination of the serum concentration (pg/mL) of TNF-alpha | 3 months | 
| Serum IL-12 levels | Determination of the serum concentration (pg/mL) of IL-12 | 3 months | 
| Serum IL-4 levels | Determination of the serum concentration (pg/mL) of IL-4 | 3 months | 
| Serum IL-10 levels | Determination of the serum concentration (pg/mL) of IL-10 | 3 months | 
| Serum TGF-beta levels | Determination of the serum concentration (pg/mL) of TGF-beta | 3 months | 
| Fecal levels of Bifidobacterium | Determination of the levels (log cells/gr) of Bifidobacterium in fecal samples by qPCR | 3 months | 
| Fecal levels of Lactobacillus | Determination of the levels (log cells/gr) of Lactobacillus in fecal samples by qPCR | 3 months | 
| Fecal levels of Bacteroides | Determination of the levels (log cells/gr) of Bacteroides in fecal samples by qPCR | 3 months | 
| Fecal levels of Blautia | Determination of the levels (log cells/gr) of Blautia in fecal samples by qPCR | 3 months | 
| Fecal levels of Akkermansia | Determination of the levels (log cells/gr) of Akkermansia in fecal samples by qPCR | 3 months | 
| Fecal levels of Faecalibacterium | Determination of the levels (log cells/gr) of Faecalibacterium in fecal samples by qPCR | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Functional dyspepsia, Abdominal pain, Flatulence, Bifidobacterium, Lactobacillus