Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 9, 2019
January 1, 2019
4 years
July 26, 2016
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Normalization of stool consistency
Normalization according to Bristol stool scale
90 days
Secondary Outcomes (1)
Normalization of stool frequency
90 days
Study Arms (3)
Vancomycin
ACTIVE COMPARATORSecondary treatment for relapse of Clostridium difficile infection.
Cultured human intestinal microbiota1
EXPERIMENTALCultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Cultured human intestinal microbiota2
EXPERIMENTALCultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Interventions
Secondary treatment for C diff in replacement for regular vancomycin.
Primary treatment for C diff in all treatment arms
Eligibility Criteria
You may qualify if:
- Antibiotic-induced diarrhea
- Positive fecal analysis for Clostridium difficile toxin
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Per Hellströmlead
- Karolinska Institutetcollaborator
- Region Gävleborgcollaborator
Study Sites (1)
Gävle Hospital
Gävle, Gävleborg County, 801 87, Sweden
Related Publications (5)
van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PMID: 23323867RESULTBakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.
PMID: 21871249RESULTHusebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T. Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G368-80. doi: 10.1152/ajpgi.2001.280.3.G368.
PMID: 11171619RESULTGustafsson A, Berstad A, Lund-Tonnesen S, Midtvedt T, Norin E. The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea. Scand J Gastroenterol. 1999 Jun;34(6):580-6. doi: 10.1080/003655299750026038.
PMID: 10440607RESULTGustafsson A, Lund-Tonnesen S, Berstad A, Midtvedt T, Norin E. Faecal short-chain fatty acids in patients with antibiotic-associated diarrhoea, before and after faecal enema treatment. Scand J Gastroenterol. 1998 Jul;33(7):721-7. doi: 10.1080/00365529850171666.
PMID: 9712236RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hellström M Per, MD, PhD
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 26, 2016
First Posted
August 5, 2016
Study Start
October 1, 2014
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
January 9, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share