NCT02928484

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

September 7, 2016

Last Update Submit

October 7, 2016

Conditions

Signs and Symptoms, DigestiveDyspepsia

Keywords

Functional dyspepsiaAbdominal painFlatulenceProbioticsBifidobacteriumLactobacillus

Outcome Measures

Primary Outcomes (1)

  • Functional dyspepsia symptoms

    Physician determined symptoms according to Rome III criteria.

    3 months

Secondary Outcomes (14)

  • Relative proportions of the main microbial groups of the intestinal microbiota

    3 months

  • Dyspepsia associated quality of life

    3 months

  • Serum IFN-gamma levels

    3 months

  • Serum TNF-alpha levels

    3 months

  • Serum IL-12 levels

    3 months

  • +9 more secondary outcomes

Study Arms (2)

Test product

ACTIVE COMPARATOR

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

Placebo product

PLACEBO COMPARATOR

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

Interventions

Probiotic mix CBP-004019/CDIETARY_SUPPLEMENT

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

Test product
PlaceboDIETARY_SUPPLEMENT

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

Placebo product

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria

You may not qualify if:

  • Celiac disease or other organic GI disease
  • Orthorexia nervosa or other eating disorders
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

MeSH Terms

Conditions

Signs and Symptoms, DigestiveDyspepsiaAbdominal PainFlatulence

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Adolfo Suárez, MD, PhD

    Hospital Universitario Central de Asturias, Servicio de Gastroenterología

    PRINCIPAL INVESTIGATOR

  • Miguel Gueimonde, PhD

    Consejo Superior de Investigaciones Científicas, IPLA-CSIC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Empar Chenol, PhD

CONTACT

+34963160299empar.chenoll@biopolis.es

Salvador Genoves, PhD

CONTACT

+34963160299salvador.genoves@biopolis.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

October 10, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

ES(1)