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: 
12 Oct 2020
Reviewer's report:
This is a small randomized controlled trial of FMT for induction of active UC.
The study used antibiotic pretreatment followed by colonoscopic delivery of
FMT and then oral capsule delivery for 12 weeks. The study enrolled 6 patients
in the FMT group and 6 in the placebo group. 
This study is of interest due to the use of capsule FMT delivery, however the
number of patients enrolled is too small to derive meaningful clinical data. FMT
does appear safe in this setting, however 6 patients receiving active treatment is
too few to determine safety. 
Study design: Please indicate the definition of clinical response and remission of
UC in this trial. 
Clinical and histologic outcomes page 11: 
* Please outline the number of patients who achieved the clinical endpoint of
remission in both groups. 
* Differences between the groups should be presented with CI and p values. 
* There were 3/6 patients in the FMT group who demonstrated improvement in
clinical indices however the definition of clinical response and clinical remission
have not been defined earlier in the paper and so this information is not able to
be interpreted. 
Discussion. Line 456. It is not possible to say that this trial demonstrated a
striking differentiation of patients into responders and non-responders. 
UC is a
relapsing and remitting disease and with 6 patients undergoing FMT the
numbers are too small to make such conclusions. 
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Declaration of competing interests
Please complete a declaration of competing
interests, considering the following questions:
1
. 
Have you in the past five years received reimbursements, fees, funding, or
salary from an organisation that may in any way gain or lose financially
from the publication of this manuscript, either now or in the future?
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Do you hold any stocks or shares in an organisation that may in any way
gain or lose financially from the publication of this manuscript, either now
or in the future?
3
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Do you hold or are you currently applying for any patents relating to the
content of the manuscript?
4
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Have you received reimbursements, fees, funding, or salary from an
organization that holds or has applied for patents relating to the content of
the manuscript?
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Do you have any other financial competing interests?
6
. 
Do you have any non-financial competing interests in relation to this
paper?
If you can answer no to all of the above, write 'I declare that I have no competing
interests' below. If your reply is yes to any, please give details below.
I have shares in an Australian stool bank that provides FMT. There is no direct
conflict of interest.
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes