Intestinal Decolonization MedDRA version: 17.0 Level: LLT Classification code 10069718 Term: Bacterial colonization System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Emportal
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: AC1L3M5J
CAS Number: 81025-04-9
Other descriptive name: LACTITOL MONOHYDRATE
Concentration unit: g gra
Sponsors
Fundacion para La Investigación Biomédica Hospital Universitario La Paz (FIBHULP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men and women between 18 and 75 years ? 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum), administered orally to achieve intestinal decolonization of KP-OXA-48 in people after 6 weeks of completing treatment (Sustained Response) .;Secondary Objective: ?Evaluate the effectiveness of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) administered orally for intestinal decolonization of KP- OXA -48 in people at the time of the end of treatment ( End of treatment Response) and 3 weeks after end of treatment ( Short-term response ) . ? To evaluate the safety and tolerability of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) orally administered to people with KP- OXA -48 . ? 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 .;Primary end point(s): ? Response to treatment: if the presence of KP-OXA-48 in fecal / rectal sample was not detected at the end of treatment visit. ? Short Term Response: If the presence of KP-OXA-48 is not detected in rectal / fecal sample three weeks after treatment ended (V7) or any visits since the end of treatment ? Long-term Response (primary endpoint) in patients with short-term response that 6 weeks after the end of treatment visit theOXA-48 KP is not detected;Timepoint(s) of evaluation of this end point: V4: Visit End of treatment (Day 21 + / - 2) V7: Follow up Visit S3 (Day 42 + / - 2) V8: End of Follow up visit S4 (Day 63 + / - 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability Microbiological determinations;Timepoint(s) of evaluation of this end point: During all the study | — |
Countries
Spain
Contacts
Public ContactMaria Posada
FIBHULP
Outcome results
None listed