Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Biopolis

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Signs and Symptoms, Digestive; Dyspepsia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic mix CBP-004019/C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02928484

CIEN-HUCA-IPLA

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Test product

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic mix CBP-004019/C

Placebo product

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo