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Table 3 Details of SAEs

From: Adverse events of intestinal microbiota transplantation in randomized controlled trials: a systematic review and meta-analysis

 

Moayyedi et al.

[34]

Paramsothy et al.

[37]

Costello et al.

[41]

Huttner et al.

[42]

Hvas et al.

[43]

IMT

Two persons developed patchy inflammation of the colon and also rectal abscess formation, which resolved with antibiotic therapy

One was Clostridium difficile toxin positive at the end of therapy

One patient with refractory ulcerative colitis who was assigned IMT withdrew at week 2 because of clinical and endoscopic deterioration and underwent colectomy

One patient with moderately severe colitis who was assigned IMT remained unwell at week 3, withdrew from the study, and was admitted for intravenous corticosteroid therapy

One patient developed worsening colitis

One patient developed clostridium difficile colitis requiring colectomy

One patient developed pneumonia

Female, 57 years, Utrecht Patient with known liver cirrhosis and recurrent episodes of hepatic encephalopathy hospitalized 2 weeks after IMT for episode of encephalopathy

A 50-year-old woman developed a sepsis-like clinical picture with pyrexia, convulsions, vomiting, and diarrhea in her private home for 3 h the evening after an uncomplicated IMT delivered by colonoscopy. Although perceived life-threatening, the patient was not admitted to the hospital and had complete recovery within 24 h without further treatment

CON

One person in the placebo group developed worsening colitis and was admitted to hospital 3 weeks into the trial and had an urgent colectomy

One person developed patchy inflammation of the colon and also rectal abscess formation, which resolved with antibiotic therapy

One patient with moderately severe colitis who was allocated placebo withdrew at week 3 and needed hospitalization

Two SAEs in the aIMT group (both worsening colitis)

Male, 68 years, Paris, Two hospitalizations for recurrent urinary tract infection

Female 56 years, Utrecht, Hospitalization for pyelonephritis

No SAE

  1. IMT intestinal microbiota transplantation, aIMT autoplastic intestinal microbiota transplantation, CON control, SAE serious adverse event, SOC standard of care, HE hepatic encephalopathy