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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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ClinicalTrials.gov Identifier: NCT02307383
Recruitment Status : Unknown
Verified December 2014 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Bacterial Colonization Drug: Lactitol Drug: Lactobacillus Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 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.

Drug: Lactitol
Other Name: Emportal

Drug: Lactobacillus
Other Name: Infloran Berna




Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people. [ Time Frame: 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).

  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307383


Contacts
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Contact: Juan Carlos Ramos +34912071876 ramosramosjc@gmail.com

Locations
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Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Juan Carlos Ramos       ramosramosjc@gmail.com   
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Francisco Arnalich, PhD Hospital Universitario La Paz

Additional Information:
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02307383     History of Changes
Other Study ID Numbers: Desprobioxa
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
SDD (Selective Digestive Decolonization)
OXA 48
carbapenemase
probiotics
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lactitol
Cathartics
Gastrointestinal Agents