Diabetes Mellitus, Type 2NCT04191525
Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus
A study testing BPL-1 Probiotic capsules in people with Diabetes Mellitus, Type 2, run by Mónica Marazuela Azpíroz at 1 site in Spain.
Trial summary
Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and macrovascular complications associated with the increased prevalence of cardiovascular disease (CVD) in diabetics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BPL-1 Probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2018to 26 Jun 2019
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18-75 (inclusive)
- BMI ≥ 27
- Glycated hemoglobin > 5,6 and/or fasting glucose > 100 mg/dl and/or being on active treatment with at least one antidiabetic medication
- Subjects must be able to provide written informed consent
- Females of childbearing potential must have a previous negative pregnancy test and must agree to use adequate contraception during their participation in the study
Who cannot join
- Crohn's disease, liver cirrhosis, human immunodeficiency virus (HIV) or any other active systemic bacterial, viral or fungal infections
- BMI > 42
- Severe hypoglycemias within 3 months prior to the start date of the study
- Abnormal glycated hemoglobin measurements (over 8%) prior to the start date of the study
- Prescription of a new antidiabetic medication in the last 6 months
- Celiac disease or any other food intolerances
Show all 11Show fewer
- Use of antibiotics, probiotics and/or prebiotics within 2 weeks prior to the start date of the study
- Chronic liver disease with a C Child-Plug score, chronic kidney disease with creatinine clearance < 50 ml/min as well as any other clinically significant conditions including pulmonary, neurological and cardiovascular diseases according to the investigators medical opinion
- Patients with history or presence of malignancy who have been treated with systemic antineoplastic therapy within 6 months prior to the start date of the study
- Pregnancy and breastfeeding
- Not being able to provide written informed consent to participate in the study or to cooperate and comply with the study procedures for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12 Week, Randomized, Double-blind, Placebo-controlled, Phase II Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus With Different Course of Disease and Treatment
Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and macrovascular complications associated with the increased prevalence of cardiovascular disease (CVD) in diabetics.
Although genetic predisposition determines individual susceptibility to T2DM, external factors such as an unhealthy diet and a sedentary lifestyle condition the onset of the disease.
Read more
Since T2DM is a multifactorial disease, many authors have studied the possible role of the microbiota and its alterations in the pathophysiology of the disease. There is evidence that in T2DM there are alterations in the proportion of Firmicutes, Bacteroidetes and Proteobacteria, and a smaller amount of bifidobacteria with anti-inflammatory properties.
Probiotics are living microorganisms present in food that, if consumed in sufficient quantities, can improve health. In general, probiotics protect the patient through immunomodulation, protecting him from infections, increasing the activation of mononuclear cells and lymphocytes.
The investigational product is a supplement to the probiotic Bifidobacterium animalis subsp. lactis (BPL-1) CECT 8145. There are numerous studies carried out on different strains of GLP-1 that demonstrate its safety. Many of them are commonly used in the food industry, not only because of their proven safety, but also because of their viability until consumption.
This clinical trial is proposed as an interdisciplinary study that can contribute to the characterization of the efficacy of treatment with probiotics in patients with T2DM of different stages of evolution, without and with hepatic involvement.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BPL-1 Probiotic capsules, Placebo
- Keywords
- Diabetes Mellitus, Microbiote, Cardiovascular Risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPL-1 Probiotic capsulesDietary supplement
BPL-1 Probiotic 1 capsule/day
PlaceboDietary supplement
Placebo masked with the same presentation as the experimental product 1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| BPL-1 Probiotic capsules | Experimental | BPL-1 Probiotic 1 capsule/day Receives: Dietary Supplement: BPL-1 Probiotic capsules |
| Placebo | Placebo comparator | 1 capsule/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Fasting glucose
Measured: 12 weeks
Glycated haemoglobin
Glycated haemoglobin
Measured: 12 weeks
Insulin
Insulin
Measured: 12 weeks
HOMA-IR
HOMA-IR
Measured: 12 weeks
Secondary outcomes (8)
Total cholesterol
Total cholesterol
Measured: 12 weeks
HDL-cholesterol
HDL-cholesterol
Measured: 12 weeks
LDL-cholesterol
LDL-cholesterol
Measured: 12 weeks
Triglycerides
Triglycerides
Measured: 12 weeks
Body Mass Index (BMI)
Body Mass Index (BMI)
Measured: 12 weeks
Body Fat Percentage (%BF)
Body Fat Percentage (%BF)
Measured: 12 weeks
Blood pressure
Blood pressure
Measured: 12 weeks
Waist perimeter
Waist perimeter
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start10 Sep 2018
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, randomized, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mónica Marazuela Azpíroz
- Sponsor type
- University, hospital or other
- Collaborators
- Alba Garcimartín Álvarez, Carolina Knott Torcal, Nerea Aguirre Moreno, Miguel Antonio Sampedro Núñez, María Caldas, Belén Ruiz-Rosso, Ana María Ramos Levi
- Responsible party
- Sponsor-investigator, Mónica Marazuela Azpíroz, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Mónica Marazuela Azpíroz, MD PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191525
- Sponsor's protocol ID
- PROBIDEM
- Status last verified
- Jul 2020
- First submitted
- 5 Dec 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week, Randomized, Double-blind, Placebo-controlled, Phase II Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus With Different Course of Disease and Treatment
- ClinicalTrials.gov ID
- NCT04191525
- Acronym / sponsor ID
- PROBIDEM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Microbiote, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mónica Marazuela AzpírozUniversity, hospital or other
- Collaborators
- Alba Garcimartín Álvarez, Carolina Knott Torcal, Nerea Aguirre Moreno, Miguel Antonio Sampedro Núñez, María Caldas, Belén Ruiz-Rosso, Ana María Ramos Levi
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 9 Dec 2019 (actual)
- 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.
Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and macrovascular complications associated with the increased prevalence of cardiovascular disease (CVD) in diabetics.
Although genetic predisposition determines individual susceptibility to T2DM, external factors such as an unhealthy diet and a sedentary lifestyle condition the onset of the disease.
Since T2DM is a multifactorial disease, many authors have studied the possible role of the microbiota and its alterations in the pathophysiology of the disease. There is evidence that in T2DM there are alterations in the proportion of Firmicutes, Bacteroidetes and Proteobacteria, and a smaller amount of bifidobacteria with anti-inflammatory properties.
Probiotics are living microorganisms present in food that, if consumed in sufficient quantities, can improve health. In general, probiotics protect the patient through immunomodulation, protecting him from infections, increasing the activation of mononuclear cells and lymphocytes.
The investigational product is a supplement to the probiotic Bifidobacterium animalis subsp. lactis (BPL-1) CECT 8145. There are numerous studies carried out on different strains of GLP-1 that demonstrate its safety. Many of them are commonly used in the food industry, not only because of their proven safety, but also because of their viability until consumption.
This clinical trial is proposed as an interdisciplinary study that can contribute to the characterization of the efficacy of treatment with probiotics in patients with T2DM of different stages of evolution, without and with hepatic involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-centre, randomized, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| BPL-1 Probiotic capsules | Experimental | Dietary Supplement: BPL-1 Probiotic capsulesBPL-1 Probiotic 1 capsule/day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients between the ages of 18-75 (inclusive)
- BMI ≥ 27
- Glycated hemoglobin > 5,6 and/or fasting glucose > 100 mg/dl and/or being on active treatment with at least one antidiabetic medication
- Subjects must be able to provide written informed consent
- Females of childbearing potential must have a previous negative pregnancy test and must agree to use adequate contraception during their participation in the study
Key exclusion criteria (11 listed)
- Crohn's disease, liver cirrhosis, human immunodeficiency virus (HIV) or any other active systemic bacterial, viral or fungal infections
- BMI > 42
- Severe hypoglycemias within 3 months prior to the start date of the study
- Abnormal glycated hemoglobin measurements (over 8%) prior to the start date of the study
- Prescription of a new antidiabetic medication in the last 6 months
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 |
|---|---|---|
| BPL-1 Probiotic capsulesBPL-1 Probiotic 1 capsule/day | Dietary supplement | BPL-1 Probiotic capsules |
| PlaceboPlacebo masked with the same presentation as the experimental product 1 capsule/day | Dietary supplement | Placebo |
Primary outcome
Fasting glucose
Time frame: 12 weeks
Fasting glucose
Glycated haemoglobin
Time frame: 12 weeks
Glycated haemoglobin
Insulin
Time frame: 12 weeks
Insulin
HOMA-IR
Time frame: 12 weeks
HOMA-IR
8 secondary outcomes
Total cholesterol
Time frame: 12 weeks
HDL-cholesterol
Time frame: 12 weeks
LDL-cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Body Mass Index (BMI)
Time frame: 12 weeks
Body Fat Percentage (%BF)
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Waist perimeter
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Mónica Marazuela Azpíroz, MD PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPL-1 Probiotic capsules in people with Diabetes Mellitus, Type 2, run by Mónica Marazuela Azpíroz 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jul 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 8 Jul 2020.