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

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Unknown; Phase 2

Conditions: Bacterial Colonization

Treatments: Drug: Lactitol; Drug: Lactobacillus

Study type: Interventional

Funder types: Other

Identifiers

NCT02307383

Desprobioxa

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lactitol and Lactobacillus

Experimental group

Description:

Lactitol monohydrated 10g (Emportal®), 1 sachet dissolved in water, three times a day for 21 days. Lactobacillus acidophilus, 1 x 109 UFC and Lactobacillus Biphidus 1 x 109 UFC, (Infloran Berna), 2 tablets by mouth, three times a day for 21 days.

Treatment:

Drug: Lactobacillus

Drug: Lactitol