Signs and Symptoms, DigestivePhase 1/2NCT02928484
Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function
A Phase 1/2 study testing Probiotic mix CBP-004019/C in people with Signs and Symptoms, Digestive and Dyspepsia, run by Biopolis S.L. at 1 site in Spain.
Trial summary
The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Digestive, Dyspepsia
- What is being tested?
- Probiotic mix CBP-004019/C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Adolfo Suárez, MD, PhD, +34985108000, adolfo.suarez@hcabuenes.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Signs and Symptoms, Digestive, Dyspepsia
- Being tested
- Probiotic mix CBP-004019/C, Placebo
- Keywords
- Functional dyspepsia, Abdominal pain, Flatulence, Probiotics, Bifidobacterium, Lactobacillus
- Medical subject headings
- Signs and Symptoms, Digestive, Dyspepsia, Abdominal Pain, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mix CBP-004019/CDietary supplement
One capsule per day of the probiotic mix CBP-004019/C during one month.
PlaceboDietary supplement
One capsule per day of the placebo (maltodextrin) during one month.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional dyspepsia symptoms
Physician determined symptoms according to Rome III criteria.
Measured: 3 months
Secondary outcomes (14)
Relative proportions of the main microbial groups of the intestinal microbiota
Global profile of intestinal microbiota composition established by 16S rRNA profiling
Measured: 3 months
Dyspepsia associated quality of life
Questionaires for symptoms and QoL associated to dyspepsia and for anxiety/depression
Measured: 3 months
Serum IFN-gamma levels
Determination of the serum concentration (pg/mL) of IFN-gamma
Measured: 3 months
Serum TNF-alpha levels
Determination of the serum concentration (pg/mL) of TNF-alpha
Measured: 3 months
Serum IL-12 levels
Determination of the serum concentration (pg/mL) of IL-12
Measured: 3 months
Serum IL-4 levels
Determination of the serum concentration (pg/mL) of IL-4
Measured: 3 months
Serum IL-10 levels
Determination of the serum concentration (pg/mL) of IL-10
Measured: 3 months
Serum TGF-beta levels
Determination of the serum concentration (pg/mL) of TGF-beta
Measured: 3 months
Fecal levels of Bifidobacterium
Determination of the levels (log cells/gr) of Bifidobacterium in fecal samples by qPCR
Measured: 3 months
Fecal levels of Lactobacillus
Determination of the levels (log cells/gr) of Lactobacillus in fecal samples by qPCR
Measured: 3 months
Fecal levels of Bacteroides
Determination of the levels (log cells/gr) of Bacteroides in fecal samples by qPCR
Measured: 3 months
Fecal levels of Blautia
Determination of the levels (log cells/gr) of Blautia in fecal samples by qPCR
Measured: 3 months
Fecal levels of Akkermansia
Determination of the levels (log cells/gr) of Akkermansia in fecal samples by qPCR
Measured: 3 months
Fecal levels of Faecalibacterium
Determination of the levels (log cells/gr) of Faecalibacterium in fecal samples by qPCR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, DigestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Central de Asturias, National Research Council, Spain
- Responsible party
- Sponsor
- Investigators
- Adolfo Suárez, MD, PhD, Principal investigator, Hospital Universitario Central de Asturias, Servicio de GastroenterologíaMiguel Gueimonde, PhD, Principal investigator, Consejo Superior de Investigaciones Científicas, IPLA-CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928484
- Sponsor's protocol ID
- CIEN-HUCA-IPLA
- Status last verified
- Oct 2016
- First submitted
- 7 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal
- ClinicalTrials.gov ID
- NCT02928484
- Acronym / sponsor ID
- CIEN-HUCA-IPLA
- Conditions
- Signs and Symptoms, Digestive, Dyspepsia
- Keywords
- Functional dyspepsia, Abdominal pain, Flatulence, Probiotics, Bifidobacterium, Lactobacillus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Central de Asturias, National Research Council, Spain
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Active comparator | Dietary Supplement: Probiotic mix CBP-004019/CThe 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. |
| Placebo product | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic mix CBP-004019/COne capsule per day of the probiotic mix CBP-004019/C during one month. | Dietary supplement | Test product |
| PlaceboOne capsule per day of the placebo (maltodextrin) during one month. | Dietary supplement | Placebo product |
Primary outcome
Functional dyspepsia symptoms
Time frame: 3 months
Physician determined symptoms according to Rome III criteria.
14 secondary outcomes
Relative proportions of the main microbial groups of the intestinal microbiota
Time frame: 3 months
Dyspepsia associated quality of life
Time frame: 3 months
Serum IFN-gamma levels
Time frame: 3 months
Serum TNF-alpha levels
Time frame: 3 months
Serum IL-12 levels
Time frame: 3 months
Serum IL-4 levels
Time frame: 3 months
Serum IL-10 levels
Time frame: 3 months
Serum TGF-beta levels
Time frame: 3 months
Fecal levels of Bifidobacterium
Time frame: 3 months
Fecal levels of Lactobacillus
Time frame: 3 months
Fecal levels of Bacteroides
Time frame: 3 months
Fecal levels of Blautia
Time frame: 3 months
Fecal levels of Akkermansia
Time frame: 3 months
Fecal levels of Faecalibacterium
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Suárez, MD, PhD principal investigator
Hospital Universitario Central de Asturias, Servicio de Gastroenterología
Miguel Gueimonde, PhD principal investigator
Consejo Superior de Investigaciones Científicas, IPLA-CSIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic mix CBP-004019/C in people with Signs and Symptoms, Digestive and Dyspepsia, run by Biopolis S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Empar Chenol, PhD (+34963160299, empar.chenoll@biopolis.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional dyspepsia symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.