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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Per Hellström, Uppsala University
Sponsor:
Collaborators:
Karolinska Institutet
Region Gävleborg
Information provided by (Responsible Party):
Per Hellström, Uppsala University
ClinicalTrials.gov Identifier:
NCT02857582
First received: July 26, 2016
Last updated: August 2, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Clostridium Difficile
Biological: Cultured human intestinal microbiota
Drug: Vancomycin
Drug: Metronidazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Resource links provided by NLM:


Further study details as provided by Per Hellström, Uppsala University:

Primary Outcome Measures:
  • Normalization of stool consistency [ Time Frame: 90 days ]
    Normalization according to Bristol stool scale


Secondary Outcome Measures:
  • Normalization of stool frequency [ Time Frame: 90 days ]
    Normalization to less than three bowel movements per day


Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vancomycin
Secondary treatment for relapse of Clostridium difficile infection.
Drug: Vancomycin
Active comparator to treatment with ACHIM
Drug: Metronidazole
Primary treatment for C diff in all treatment arms
Experimental: Cultured human intestinal microbiota1
Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Biological: Cultured human intestinal microbiota
Secondary treatment for C diff in replacement for regular vancomycin.
Other Name: Anaerobic cultured human intestinal microbiota (ACHIM)
Drug: Metronidazole
Primary treatment for C diff in all treatment arms
Experimental: Cultured human intestinal microbiota2
Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Biological: Cultured human intestinal microbiota
Secondary treatment for C diff in replacement for regular vancomycin.
Other Name: Anaerobic cultured human intestinal microbiota (ACHIM)
Drug: Metronidazole
Primary treatment for C diff in all treatment arms

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02857582

Contacts
Contact: Farzad Azimi, MD +46 26154000 Farzad.Azimi@lg.se
Contact: Elisabeth Norin, PhD +46 852486726 Elisabeth.Norin@ki.se

Locations
Sweden
Gävle Hospital Recruiting
Gävle, Gävleborg, Sweden, 801 87
Contact: Elisabeth Norin, PhD    +468 52486726    Elisabeth.Norin@ki.se   
Contact: Farzad Azimi, MD    46 26154000    Farzad.Azimi@lg.se   
Sponsors and Collaborators
Per Hellström
Karolinska Institutet
Region Gävleborg
Investigators
Study Director: Hellström M Per, MD, PhD Uppsala University
  More Information

Publications:
Responsible Party: Per Hellström, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT02857582     History of Changes
Other Study ID Numbers: ACHIM 1
Study First Received: July 26, 2016
Last Updated: August 2, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Per Hellström, Uppsala University:
Antibiotic-induced diarrhea
Clostridium-difficile toxin
Pseudomembranous colitis

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Vancomycin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 25, 2017