Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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

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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.

Conditions

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Signs and Symptoms, Digestive Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test product

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.

Group Type ACTIVE_COMPARATOR

Probiotic mix CBP-004019/C

Intervention Type DIETARY_SUPPLEMENT

One capsule per day of the probiotic mix CBP-004019/C during one month.

Placebo product

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

One capsule per day of the placebo (maltodextrin) during one month.

Interventions

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Probiotic mix CBP-004019/C

One capsule per day of the probiotic mix CBP-004019/C during one month.

Intervention Type DIETARY_SUPPLEMENT

Placebo

One capsule per day of the placebo (maltodextrin) during one month.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes