Clinical trial NCT02307383: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacterial Colonization
Keywords: SDD (Selective Digestive Decolonization)
OXA 48
carbapenemase
probiotics
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.
timeFrame: Six weeks
Secondary outcomes:
measure: Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people.
timeFrame: Three weeks and six weeks
measure: 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
timeFrame: Three weeks
measure: 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
timeFrame: Three weeks
measure: 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.
timeFrame: Six weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Francisco Arnalich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.