Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
Primary Purpose
Bacterial Colonization
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Lactitol
Lactobacillus
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Colonization focused on measuring SDD (Selective Digestive Decolonization), OXA 48, carbapenemase, probiotics
Eligibility 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 .
Sites / Locations
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactitol and Lactobacillus
Arm 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.
Outcomes
Primary Outcome Measures
Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.
Secondary Outcome Measures
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).
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
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
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.
Full Information
NCT ID
NCT02307383
First Posted
November 20, 2014
Last Updated
December 4, 2014
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT02307383
Brief Title
Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Colonization
Keywords
SDD (Selective Digestive Decolonization), OXA 48, carbapenemase, probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactitol and Lactobacillus
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lactitol
Other Intervention Name(s)
Emportal
Intervention Type
Drug
Intervention Name(s)
Lactobacillus
Other Intervention Name(s)
Infloran Berna
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people.
Description
In people at the time of the end of treatment (End of treatment Response) and 3 weeks after end of treatment (Short-term response).
Time Frame
Three weeks and six weeks
Title
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
Time Frame
Three weeks
Title
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
Time Frame
Three weeks
Title
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.
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Ramos
Phone
+34912071876
Email
ramosramosjc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Arnalich, PhD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Ramos
Email
ramosramosjc@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32280375
Citation
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.
Results Reference
derived
Links:
URL
http://www.idipaz.es/
Description
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Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
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