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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02307383

Enrollment

Registered

2014-12-04

Start date

2014-10-31

Completion date

2015-10-31

Last updated

2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Colonization

Keywords

SDD (Selective Digestive Decolonization), OXA 48, carbapenemase, probiotics

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.

Interventions

DRUGLactitol

DRUGLactobacillus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—

Countries

Spain

Contacts

Primary ContactJuan Carlos Ramos

ramosramosjc@gmail.com+34912071876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026