Clinical trial NCT02928484: Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function
Official title: Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Signs and Symptoms, Digestive
Dyspepsia
Keywords: Functional dyspepsia
Abdominal pain
Flatulence
Probiotics
Bifidobacterium
Lactobacillus
Lead sponsor: Biopolis S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Central de Asturias
name: National Research Council, Spain
First posted: 2016-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional dyspepsia symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Relative proportions of the main microbial groups of the intestinal microbiota
timeFrame: 3 months
measure: Dyspepsia associated quality of life
timeFrame: 3 months
measure: Serum IFN-gamma levels
timeFrame: 3 months
measure: Serum TNF-alpha levels
timeFrame: 3 months
measure: Serum IL-12 levels
timeFrame: 3 months
measure: Serum IL-4 levels
timeFrame: 3 months
measure: Serum IL-10 levels
timeFrame: 3 months
measure: Serum TGF-beta levels
timeFrame: 3 months
measure: Fecal levels of Bifidobacterium
timeFrame: 3 months
measure: Fecal levels of Lactobacillus
timeFrame: 3 months
measure: Fecal levels of Bacteroides
timeFrame: 3 months
measure: Fecal levels of Blautia
timeFrame: 3 months
measure: Fecal levels of Akkermansia
timeFrame: 3 months
measure: Fecal levels of Faecalibacterium
timeFrame: 3 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
affiliation: Hospital Universitario Central de Asturias, Servicio de Gastroenterología
name: Adolfo Suárez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consejo Superior de Investigaciones Científicas, IPLA-CSIC
name: Miguel Gueimonde, PhD
role: PRINCIPAL_INVESTIGATOR
References: