Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
NCT ID: NCT02307383
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2014-10-31
2015-10-31
Brief Summary
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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 Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lactitol and Lactobacillus
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.
Lactitol
Lactobacillus
Interventions
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Lactitol
Lactobacillus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 .
18 Years
ALL
No
Sponsors
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Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Francisco Arnalich, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Juan Carlos Ramos
Role: primary
References
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Ramos-Ramos JC, Lazaro-Perona F, Arribas JR, Garcia-Rodriguez J, Mingorance J, Ruiz-Carrascoso G, Borobia AM, Pano-Pardo JR, Herruzo R, Arnalich F. Proof-of-concept trial of the combination of lactitol with Bifidobacterium bifidum and Lactobacillus acidophilus for the eradication of intestinal OXA-48-producing Enterobacteriaceae. Gut Pathog. 2020 Apr 7;12:15. doi: 10.1186/s13099-020-00354-9. eCollection 2020.
Related Links
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Related Info
Other Identifiers
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Desprobioxa
Identifier Type: -
Identifier Source: org_study_id