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

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Treatments: Lactitol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 .