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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-01

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.

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Detailed Description

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Conditions

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Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vancomycin

Secondary treatment for relapse of Clostridium difficile infection.

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Active comparator to treatment with ACHIM

Metronidazole

Intervention Type DRUG

Primary treatment for C diff in all treatment arms

Cultured human intestinal microbiota1

Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.

Group Type EXPERIMENTAL

Cultured human intestinal microbiota

Intervention Type BIOLOGICAL

Secondary treatment for C diff in replacement for regular vancomycin.

Metronidazole

Intervention Type DRUG

Primary treatment for C diff in all treatment arms

Cultured human intestinal microbiota2

Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.

Group Type EXPERIMENTAL

Cultured human intestinal microbiota

Intervention Type BIOLOGICAL

Secondary treatment for C diff in replacement for regular vancomycin.

Metronidazole

Intervention Type DRUG

Primary treatment for C diff in all treatment arms

Interventions

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Cultured human intestinal microbiota

Secondary treatment for C diff in replacement for regular vancomycin.

Intervention Type BIOLOGICAL

Vancomycin

Active comparator to treatment with ACHIM

Intervention Type DRUG

Metronidazole

Primary treatment for C diff in all treatment arms

Intervention Type DRUG

Other Intervention Names

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Anaerobic cultured human intestinal microbiota (ACHIM)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No