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

Phase 2

Completed

• Conditions: Clostridium Difficile
• Interventions: Drug: Vancomycin; Biological: Cultured human intestinal microbiota; Drug: Metronidazole

• Registration Number: NCT02857582
• Lead Sponsor: Per Hellström

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2018-10
• Study Completion: 2018-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	Secondary treatment for relapse of Clostridium difficile infection.
Cultured human intestinal microbiota1	Cultured human intestinal microbiota	Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Cultured human intestinal microbiota1	Metronidazole	Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Cultured human intestinal microbiota2	Cultured human intestinal microbiota	Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Cultured human intestinal microbiota2	Metronidazole	Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Vancomycin	Metronidazole	Secondary treatment for relapse of Clostridium difficile infection.

Primary Outcome Measures

Name	Time	Method
Normalization of stool consistency	90 days	Normalization according to Bristol stool scale

Secondary Outcome Measures

Name	Time	Method
Normalization of stool frequency	90 days	Normalization to less than three bowel movements per day

Trial Locations

Locations (1)

Gävle Hospital; 🇸🇪 Gävle, Gävleborg, Sweden