Review for 10.1186/s12876-021-01856-9 (2021)

Reviewer’s report
Title: 
Daily, Oral FMT for Long-term Maintenance Therapy in Ulcerative
Colitis: Results of a single-center, prospective, randomized pilot study.
Version: 
0 
Date: 
15 Sep 2020
Reviewer's report:
The authors conducted a small randomised study where 12 patients with active
ulcerative colitis received either FMT or placebo applied as a high dose
induction by colonoscopy followed by low dose maintenance capsule therapy.
Most endpoints were reported at 12 weeks follow-up, and clinical follow-up was
extended to 36 weeks. The trial investigated safety and feasibility and was not
powered to demonstrate clinical efficacy. Faecal microbiota profiling by 16S
sequencing and flow cytometry investigating PBMC MAIT and Treg phenotypes
provided exploratory results. 
Although limited in sample size, the study provides useful pilot data to guide the
design of future efficacy trials. Reassuringly, it does not report serious adverse
events related to the treatment. Some suggestions that may be addressed to
improve the impact of the paper:
1. Please describe how faecal samples were conserved (line 189)
2. Clinical follow-up at week 4,8,12,18,36 would ideally allow a graphical
presentation of development in clinical disease indexes, enabling a discussion of
time to effect and the sustainability of the effect observed. This is important
because clinical changes in the FMT group and the placebo group appear similar,
and this should be highlighted. 
3. A brief discussion of donor selection and the reason to provide faeces from
two donors to each patient may be included. 
4. In the trial protocol, inclusion of 20 subjects was planned. Why were only 12
treated? Dificulties to recruit patients? Previous studies indicated high patient
willingness to receive FMT.
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