Status:
UNKNOWN
Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Bacterial Colonization
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Men and women over 18 years old
- Have signed the informed consent to participate.
- Have evidence of intestinal colonization by KP-OXA-48 during the period of screening.
- Start of intestinal colonization by KP-OXA-48, \> 6 months of starting treatment.
- Absence of exclusion criteria
Exclusion
- Be hospitalized for an acute process at the time of inclusion.
- Take antibiotics (oral , intramuscular or intravenous ) at the time of inclusion.
- Having diarrhea in the two weeks prior to the inclusion.
- Baseline electrolyte abnormalities requiring supplementation : Hypokalemia (K \<3 mEq / L), hypomagnesemia (Mg \<1.8 mEq / L ), hypocalcemia (Ca \< 8mg/dL )
- Suffering from digestive diseases : Crohn's disease, ulcerative colitis , celiac disease, irritable bowel syndrome , intestinal resection, colostomies.
- Neutropenia ( neutrophil count \< 1.00 x 10 3 / uL ) or other situations of severe immunosuppression , including continued use of systemic steroids (at least 1mg/kg/day of prednisone or equivalent for more than 1 month) and other forms of pharmacological immunosuppression deemed by the investigator.
- Diabetes mellitus poorly controlled ( HgA1c \> 8 mmol / mol ).
- Taking antisecretory inhibitors, proton pump or anti -H2.
- Advanced chronic renal failure (GFR \< 30 ml / min)
- Being a carrier of endovascular prosthetic devices, including long-term central catheters.
- Having significant valvulopathy on the opinion of the investigator.
- Surgical intervention of gastrointestinal tract in the last three months.
- Treatment with systemic corticosteroids or immunosuppressive.
- Allergy or intolerance to lactose or lactitol or Infloran .
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02307383
Start Date
October 1 2014
End Date
October 1 2015
Last Update
December 5 2014
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046