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

Bacterial Colonization Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02307383
• Other study ID #: Desprobioxa
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2014
• Last updated: December 4, 2014
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Juan Carlos Ramos
• Phone: +34912071876
• Email: ramosramosjc[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 .

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Colonization

Intervention

Drug:
• Lactitol

• Lactobacillus

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.		Six weeks	No
Secondary	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).	Three weeks and six weeks	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Link