Gastrointestinal eradication of multi-resistant gram negative bacteria by faecal microbiota transplantation (FMT)

Not Applicable

Recruiting

• Conditions: infection; Infection - Other infectious diseases

• Registration Number: ACTRN12617000561381
• Lead Sponsor: The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-21
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Patients with refractory or recurrent infection–defined as at least 3 episodes of infection requiring at least 3 episodes of antibiotic therapy in preceding 24 months.
2. These infections were caused by a Gram negative bacterium which has acquired clinically important antibiotic resistance. This is defined as reported resistance to one or more of the following antibiotics: meropenem, ceftriaxone, cefepime, ceftazidime, cefalexin, amoxicillin-clavulanate, piperacillin-tazobactam, ciprofloxacin, gentamicin or trimethoprim.

Exclusion Criteria

1. Active gastrointestinal infection
Ie bacterial or viral infection causing symptoms of diarrhoea
(colonisation with MRGNB is not considered to be an infection)
2. Pregnancy
3. Current use of antibiotics*
4. Cognitive impairment
5. Perianal inflammation
6. Life expectancy < 1 year
7. Neutropaenia <0.5 X109/L
8. Severe IgE mediated food allergy : urticaria or anaphylaxis
9. At risk of peritonitis: including patients with ascities or peritoneal dialysis
*The use of trimethoprim-sulfamethoxazole is allowed when used for prophylaxis against Pneumocystis infection in immunosuppressed individuals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified