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

NCT02857582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile

Interventions

BIOLOGICAL

Cultured human intestinal microbiota

Secondary treatment for C diff in replacement for regular vancomycin.

DRUG

Vancomycin

Active comparator to treatment with ACHIM

DRUG

Metronidazole

Primary treatment for C diff in all treatment arms

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Region Gävleborg

    collaborator OTHER

  • Per Hellström

    lead OTHER

Principal Investigators

  • Hellström M Per, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-10-31
Completion
2018-12-01

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02857582 on ClinicalTrials.gov