Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus

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.

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

BPL-1 Probiotic capsules

BPL-1 Probiotic 1 capsule/day

DIETARY_SUPPLEMENT

Placebo

Placebo masked with the same presentation as the experimental product 1 capsule/day

Sponsors & Collaborators

• Alba Garcimartín Álvarez

  collaborator UNKNOWN

• Carolina Knott Torcal

  collaborator UNKNOWN

• Nerea Aguirre Moreno

  collaborator UNKNOWN

• Miguel Antonio Sampedro Núñez

  collaborator UNKNOWN

• María Caldas

  collaborator UNKNOWN

• Belén Ruiz-Rosso

  collaborator UNKNOWN

• Ana María Ramos Levi

  collaborator UNKNOWN

• Mónica Marazuela Azpíroz

  lead OTHER

Principal Investigators

• Mónica Marazuela Azpíroz, MD PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-10

Primary Completion

2019-06-26

Completion

2019-06-26

Countries

• Spain

Study Locations