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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bacterial Colonization

Intervention / Treatment
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* Drug: Lactitol
* Drug: Lactobacillus


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactitol and Lactobacillus<br>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. | Drug: Lactitol<br> <br> * Other names: Emportal;Drug: Lactobacillus<br> <br> * Other names: Infloran Berna;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people. |  | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people. | In people at the time of the end of treatment (End of treatment Response) and 3 weeks after end of treatment (Short-term response). | Three weeks and six weeks | 
| 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 |  | 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 |  | 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. |  | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OXA 48, SDD (Selective Digestive Decolonization), carbapenemase, probiotics