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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02928484
Other study ID # CIEN-HUCA-IPLA
Secondary ID
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


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
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