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

NCT02307383 | Unknown Phase 2

• 1 other identifier: Desprobioxa
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Colonization

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people.

  Three weeks and six weeks

• 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

Study Arms (1)

Lactitol and Lactobacillus

EXPERIMENTAL

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; Drug: Lactobacillus

Interventions

Lactitol DRUG

Also known as: Emportal

Lactitol and Lactobacillus

Lactobacillus DRUG

Also known as: Infloran Berna

Lactitol and Lactobacillus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 32280375 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

lactitol; Lacteol

Study Officials

• Francisco Arnalich, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos Ramos

CONTACT

+34912071876; ramosramosjc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: December 4, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

ES (1)