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

Clostridium Difficile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857582
• Other study ID #: ACHIM 1
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

Intervention

Biological:
• Cultured human intestinal microbiota
Secondary treatment for C diff in replacement for regular vancomycin.

Drug:
• Vancomycin
Active comparator to treatment with ACHIM
• Metronidazole
Primary treatment for C diff in all treatment arms

Locations

Country	Name	City	State
Sweden	Gävle Hospital	Gävle	Gävleborg

Sponsors (3)

Lead Sponsor	Collaborator
Per Hellström	Karolinska Institutet, Region Gävleborg

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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 trans — View Citation

Gustafsson A, Berstad A, Lund-Tønnesen 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. — View Citation

Gustafsson A, Lund-Tønnesen 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. — View Citation

Husebye E, Hellström 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. — View 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;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of stool consistency	Normalization according to Bristol stool scale	90 days
Secondary	Normalization of stool frequency	Normalization to less than three bowel movements per day	90 days