Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers
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|ClinicalTrials.gov Identifier: NCT02307383|
Recruitment Status : Unknown
Verified December 2014 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was: Recruiting
First Posted : December 4, 2014
Last Update Posted : December 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Colonization||Drug: Lactitol Drug: Lactobacillus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Experimental: Lactitol and Lactobacillus
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.
Other Name: Emportal
Other Name: Infloran Berna
- Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people. [ Time Frame: Six weeks ]
- Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Six weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307383
|Contact: Juan Carlos Ramosemail@example.com|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Juan Carlos Ramos firstname.lastname@example.org|
|Principal Investigator:||Francisco Arnalich, PhD||Hospital Universitario La Paz|