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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactitol | Drug |
|
| |
| Lactobacillus |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Ramos | Contact | +34912071876 | ramosramosjc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Arnalich, PhD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32280375 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Drug |
|
|
| 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 |
| ID | Term |
|---|---|
| C014635 | lactitol |
| C100843 | Lacteol |
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