Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Study Overview
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Brief Summary
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Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.

Official Title
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Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Conditions
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Clostridium Difficile

Intervention / Treatment
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* Biological: Cultured human intestinal microbiota
* Drug: Vancomycin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Antibiotic-induced diarrhea Positive fecal analysis for Clostridium difficile toxin Exclusion Criteria: Antibiotic treatment Probiotic treatment Intestinal infection other than Clostridium difficile Inflammatory bowel disease (Ulcerative colitis, Crohn's disease Immunodeficiency (drug- och disease-related) Pregnancy Unable to accept endoscopic procedures Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin<br>Secondary treatment for relapse of Clostridium difficile infection. | Drug: Vancomycin<br>* Active comparator to treatment with ACHIM<br>Drug: Metronidazole<br>* Primary treatment for C diff in all treatment arms<br>|
| Experimental: Cultured human intestinal microbiota1<br>Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection. | Biological: Cultured human intestinal microbiota<br>* Secondary treatment for C diff in replacement for regular vancomycin.<br>* Other names: Anaerobic cultured human intestinal microbiota (ACHIM);Drug: Metronidazole<br>* Primary treatment for C diff in all treatment arms<br>|
| Experimental: Cultured human intestinal microbiota2<br>Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection. | Biological: Cultured human intestinal microbiota<br>* Secondary treatment for C diff in replacement for regular vancomycin.<br>* Other names: Anaerobic cultured human intestinal microbiota (ACHIM);Drug: Metronidazole<br>* Primary treatment for C diff in all treatment arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of stool consistency | Normalization according to Bristol stool scale | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of stool frequency | Normalization to less than three bowel movements per day | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic-induced diarrhea, Clostridium-difficile toxin, Pseudomembranous colitis