Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Phase 1

• Conditions: Signs and Symptoms, Digestive; Dyspepsia
• Interventions: Dietary Supplement: Probiotic mix CBP-004019/C; Dietary Supplement: Placebo

• Registration Number: NCT02928484
• Lead Sponsor: Biopolis S.L.

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-07
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test product	Probiotic mix CBP-004019/C	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.
Placebo product	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Functional dyspepsia symptoms	3 months	Physician determined symptoms according to Rome III criteria.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain