Clinical trial NCT02857582: Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
Official title: Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile
Keywords: Antibiotic-induced diarrhea
Clostridium-difficile toxin
Pseudomembranous colitis
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Region Gävleborg
First posted: 2016-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Normalization of stool consistency
timeFrame: 90 days
Secondary outcomes:
measure: Normalization of stool frequency
timeFrame: 90 days
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Gävle Hospital
state: Gävleborg
Study officials:
affiliation: Uppsala University
name: Hellström M Per, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bakken 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.
citation: Husebye 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.
citation: Gustafsson 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.
citation: Gustafsson 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.