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

Phase 2

• Conditions: Bacterial Colonization
• Interventions: Drug: Lactitol; Drug: Lactobacillus

• Registration Number: NCT02307383
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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-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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-20
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactitol and Lactobacillus	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 and Lactobacillus	Lactitol	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain