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OpenTrials
Completed

NCT Number: NCT02857582

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

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.

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Key information

Conditions

Clostridium Difficile Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Digestive System Diseases Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gävle Hospital

Gävle, Gävleborg County, 801 87, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cultured human intestinal microbiota

Biological

Secondary treatment for C diff in replacement for regular vancomycin.

Other names: Anaerobic cultured human intestinal microbiota (ACHIM)

Vancomycin

Drug

Active comparator to treatment with ACHIM

Metronidazole

Drug

Primary treatment for C diff in all treatment arms

Primary outcomes

  1. Normalization of stool consistency

    Time frame: 90 days

    Normalization according to Bristol stool scale

Secondary outcomes

  1. Normalization of stool frequency

    Time frame: 90 days

    Normalization to less than three bowel movements per day

Sponsors and collaborators

Lead sponsor

Per Hellström

Other

Collaborators

  • Karolinska Institutet
  • Region Gävleborg

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2016
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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