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

P

Per Hellström

Status and phase

Completed
Phase 2

Conditions

Clostridium Difficile

Treatments

Drug: Vancomycin
Drug: Metronidazole
Biological: Cultured human intestinal microbiota

Study type

Interventional

Funder types

Other

Identifiers

NCT02857582
ACHIM 1

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Vancomycin
Active Comparator group
Description:
Secondary treatment for relapse of Clostridium difficile infection.
Treatment:
Drug: Vancomycin
Drug: Metronidazole
Cultured human intestinal microbiota1
Experimental group
Description:
Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Treatment:
Biological: Cultured human intestinal microbiota
Drug: Metronidazole
Cultured human intestinal microbiota2
Experimental group
Description:
Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Treatment:
Biological: Cultured human intestinal microbiota
Drug: Metronidazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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