Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02928484
• Other study ID #: CIEN-HUCA-IPLA
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 7, 2016
• Last updated: October 7, 2016
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Biopolis S.L.
• Contact: Empar Chenol, PhD
• Phone: +34963160299
• Email: empar.chenoll[@]biopolis.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyspepsia
• Signs and Symptoms
• Signs and Symptoms, Digestive

Intervention

Dietary Supplement:
• Probiotic mix CBP-004019/C
One capsule per day of the probiotic mix CBP-004019/C during one month.
• Placebo
One capsule per day of the placebo (maltodextrin) during one month.

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (3)

Lead Sponsor	Collaborator
Biopolis S.L.	Hospital Universitario Central de Asturias, National Research Council, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional dyspepsia symptoms	Physician determined symptoms according to Rome III criteria.	3 months	No
Secondary	Relative proportions of the main microbial groups of the intestinal microbiota	Global profile of intestinal microbiota composition established by 16S rRNA profiling	3 months	No
Secondary	Dyspepsia associated quality of life	Questionaires for symptoms and QoL associated to dyspepsia and for anxiety/depression	3 months	No
Secondary	Serum IFN-gamma levels	Determination of the serum concentration (pg/mL) of IFN-gamma	3 months	No
Secondary	Serum TNF-alpha levels	Determination of the serum concentration (pg/mL) of TNF-alpha	3 months	No
Secondary	Serum IL-12 levels	Determination of the serum concentration (pg/mL) of IL-12	3 months	No
Secondary	Serum IL-4 levels	Determination of the serum concentration (pg/mL) of IL-4	3 months	No
Secondary	Serum IL-10 levels	Determination of the serum concentration (pg/mL) of IL-10	3 months	No
Secondary	Serum TGF-beta levels	Determination of the serum concentration (pg/mL) of TGF-beta	3 months	No
Secondary	Fecal levels of Bifidobacterium	Determination of the levels (log cells/gr) of Bifidobacterium in fecal samples by qPCR	3 months	No
Secondary	Fecal levels of Lactobacillus	Determination of the levels (log cells/gr) of Lactobacillus in fecal samples by qPCR	3 months	No
Secondary	Fecal levels of Bacteroides	Determination of the levels (log cells/gr) of Bacteroides in fecal samples by qPCR	3 months	No
Secondary	Fecal levels of Blautia	Determination of the levels (log cells/gr) of Blautia in fecal samples by qPCR	3 months	No
Secondary	Fecal levels of Akkermansia	Determination of the levels (log cells/gr) of Akkermansia in fecal samples by qPCR	3 months	No
Secondary	Fecal levels of Faecalibacterium	Determination of the levels (log cells/gr) of Faecalibacterium in fecal samples by qPCR	3 months	No