Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal

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

Study Overview

• Status: Unknown
• Conditions: Signs and Symptoms, Digestive; Dyspepsia
• Intervention / Treatment: Dietary supplement: Probiotic mix CBP-004019/C; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Empar Chenol, PhD; Phone Number: +34963160299; Email: empar.chenoll@biopolis.es
• Study Contact Backup: Name: Salvador Genoves, PhD; Phone Number: +34963160299; Email: salvador.genoves@biopolis.es

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
      • Contact: Adolfo Suárez, MD, PhD; Phone Number: +34985108000; Email: adolfo.suarez@hcabuenes.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Probiotic mix CBP-004019/C; One capsule per day of the probiotic mix CBP-004019/C during one month.
Placebo Comparator: 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.	Dietary supplement: Placebo; One capsule per day of the placebo (maltodextrin) during one month.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biopolis S.L.
• Collaborators: National Research Council, Spain; Hospital Universitario Central de Asturias
• Investigators: Principal Investigator: Adolfo Suárez, MD, PhD, Hospital Universitario Central de Asturias, Servicio de Gastroenterología; Principal Investigator: Miguel Gueimonde, PhD, Consejo Superior de Investigaciones Científicas, IPLA-CSIC

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Probiotics; Lactobacillus; Bifidobacterium; Abdominal pain; Flatulence; Functional dyspepsia
• Additional Relevant MeSH Terms: Dyspepsia; Signs and Symptoms, Digestive
• Other Study ID Numbers: CIEN-HUCA-IPLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED