NCT02908776

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: San Filippo Neri General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Stable Angina
• Periprocedural Myocardial Damage

Interventions

Type	Name	Description
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	Placebo	Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2020-01-01
• First posted: 2016-09-21
• Last updated: 2019-04-04

Locations

1 site across 1 country: Italy