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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02857582

Enrollment

Registered

2016-08-05

Start date

2014-10-31

Completion date

2018-12-01

Last updated

2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile

Keywords

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

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.

Interventions

BIOLOGICALCultured human intestinal microbiota

Secondary treatment for C diff in replacement for regular vancomycin.

DRUGVancomycin

Active comparator to treatment with ACHIM

DRUGMetronidazole

Primary treatment for C diff in all treatment arms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Normalization of stool consistency	90 days	Normalization according to Bristol stool scale

Secondary

Measure	Time frame	Description
Normalization of stool frequency	90 days	Normalization to less than three bowel movements per day

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026