Trial | NCT02908776  Report issue

Title

MYocardial DAmage AND MIcrobiota STUDY
Gut Flora Modulation for The Prevention of Pci-Related Myocardial Injury - A Randomized, Placebo Controlled, Double Blind, Investigator-Initiated, Single Centre, Preliminary Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    250
MYDA-MI study is a randomized, placebo controlled, double blind study performed in San Filippo Neri Hospital, Roma, Italy. The planned study duration is 18 months. The objectives are to assess the effects of pre-treatment with probiotic Ecoviesel on the incidence and magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable patients. 250 patients with chronic stable angina scheduled for a coronary angiography and possible ad hoc angioplasty will be randomized to receive pre-treatment with Ecoviesel sachets (each sachet contains 200 billions bacteria) or Placebo. The pre-treatment dosage will be 4 sachets of probiotic Ecoviesel or placebo for at least 2 weeks before the planned procedure. In patients undergoing angioplasty the same treatment will be continued for 4 weeks after PCI with secondary outcome measures performed at the end of this second stage.
Study Started
Sep 30
2016
Primary Completion
Sep 30
2019
Anticipated
Study Completion
Jan 31
2020
Anticipated
Last Update
Apr 04
2019

Dietary Supplement Probiotic

Sachets with Streptococcus thermophilus DSM 32245: 70 billion, bifidobacteria (Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247) 40 billion, lactobacilli (Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 29575, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961): 90 billion.

  • Other names: Ecoviesel

Other Placebo

Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.

Dietary supplement - Probiotics Experimental

4 sachets of Ecoviesel (probiotics) per day for at least 2 weeks before undergoing a coronary angiography with possible ad hoc angioplasty; and 2 sachets of probiotic per day after angioplasty, if performed.

Placebo Placebo Comparator

Sachets with inactive substance indistinguishable from Ecoviesel

Criteria 

Inclusion Criteria:

Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention

Exclusion Criteria:

Age >75 y.o
Diabetes requiring treatment
Abnormal c-TnI level before angiography
Immunodeficiency status
Need for oral vitamin K antagonists
Need for antibiotics
Use of antibiotics or probiotics within 4 weeks of enrollment
Cancer and diseases affecting 1 year prognosis
Participation in other clinical trials
No Results Posted