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

Primary Purpose

Clostridium Difficile

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Cultured human intestinal microbiota

Vancomycin

Metronidazole

About this trial

This is an interventional treatment trial for Clostridium Difficile focused on measuring Antibiotic-induced diarrhea, Clostridium-difficile toxin, Pseudomembranous colitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gävle Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Vancomycin

Cultured human intestinal microbiota1

Cultured human intestinal microbiota2

Arm Description

Secondary treatment for relapse of Clostridium difficile infection.

Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.

Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.

Outcomes

Primary Outcome Measures

Normalization of stool consistency

Normalization according to Bristol stool scale

Secondary Outcome Measures

Normalization of stool frequency

Normalization to less than three bowel movements per day

Full Information

NCT ID

NCT02857582

First Posted

July 26, 2016

Last Updated

January 7, 2019

Sponsor

Per Hellström

Collaborators

Karolinska Institutet, Region Gävleborg

1. Study Identification

Unique Protocol Identification Number

NCT02857582

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Per Hellström

Collaborators

Karolinska Institutet, Region Gävleborg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile

Keywords

Antibiotic-induced diarrhea, Clostridium-difficile toxin, Pseudomembranous colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vancomycin

Arm Type

Active Comparator

Arm Description

Secondary treatment for relapse of Clostridium difficile infection.

Arm Title

Cultured human intestinal microbiota1

Arm Type

Experimental

Arm Description

Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.

Arm Title

Cultured human intestinal microbiota2

Arm Type

Experimental

Arm Description

Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.

Intervention Type

Biological

Intervention Name(s)

Cultured human intestinal microbiota

Other Intervention Name(s)

Anaerobic cultured human intestinal microbiota (ACHIM)

Intervention Description

Secondary treatment for C diff in replacement for regular vancomycin.

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Intervention Description

Active comparator to treatment with ACHIM

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Intervention Description

Primary treatment for C diff in all treatment arms

Primary Outcome Measure Information:

Title

Normalization of stool consistency

Description

Normalization according to Bristol stool scale

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Normalization of stool frequency

Description

Normalization to less than three bowel movements per day

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hellström M Per, MD, PhD

Organizational Affiliation

Uppsala University

Official's Role

Study Director

Facility Information:

Facility Name

Gävle Hospital

City

Gävle

State/Province

Gävleborg

ZIP/Postal Code

801 87

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23323867

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.

Results Reference

result

PubMed Identifier

21871249

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.

Results Reference

result

PubMed Identifier

11171619

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.

Results Reference

result

PubMed Identifier

10440607

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.

Results Reference

result

PubMed Identifier

9712236

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.

Results Reference

result

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

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