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

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