Clinical Trial: Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Pilot Study of the Effectiveness of Probiotics and Lactitol for the Intestinal Decolonization of People Carriers of Klebsiella Pneumoniae Producers of Carbapenemase OXA-48

Brief Summary:

The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus Biphidus) administered orally is an effective strategy of intestinal decolonization of Enterobacter produced OXA-48-type carbapenemase.

The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for the intestinal decolonization of people who carried Klebsiella pneumoniae produced OXA-48-type Carbapenemase.


Detailed Summary:
Sponsor: Instituto de Investigación Hospital Universitario La Paz

Current Primary Outcome: Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people. [ Time Frame: Six weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people. [ Time Frame: Three weeks and six weeks ]
    In people at the time of the end of treatment (End of treatment Response) and 3 weeks after end of treatment (Short-term response).
  • Evaluate the safety and tolerability of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) measured by the increase of diarrhea, flatulence, abdominal pain, loss of appetite and weight loss [ Time Frame: Three weeks ]
  • Analyze the effect of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) administered orally on intestinal microbiota of carriers of KP- OXA -48 [ Time Frame: Three weeks ]
  • Evaluate the time from the start of treatment with lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) to intestinal decolonization in those patients who achieved sustained response. [ Time Frame: Six weeks ]


Original Secondary Outcome: Same as current

Information By: Instituto de Investigación Hospital Universitario La Paz

Dates:
Date Received: November 20, 2014
Date Started: October 2014
Date Completion: October 2015
Last Updated: December 4, 2014
Last Verified: December 2014