Title: Safety Comparison of Single-Donor and Pooled Fecal Microbiota Transfer Product
Preparation in Ulcerative Colitis: Systematic Review and Meta-Analysis
Version: 2 Date: 29 Jul 2024
Reviewer's report:
Interesting research topic. Some comments.
1.  METHODS -  Search strategy and selection criteria. As stated in this subheading, the the
authors should report the search strategy first in this section and the selection criteria after.
2.  METHODS - It is highly recommended that the literature search is completed within the
last 12 months before submission to ensure the review includes the most up-to-date evidence.
Would suggest updating the search.
3.  METHODS -  Most of the manuscript is a description of the methods. I would suggest
focusing more on results and discussion, which could be improved with more detail, and moving
sections from methods to supplementary materials.
4. RESULTS- Main findings from individual studies. The authors talk about "characteristics of
the 44 eligible studies..."please clarify, there were 44 identified studies, 29 of them excluded
and 15 deemed eligible.
5. RESULTS - Synthesis of results:safety assessment. Given the main goal is to assess safety,
it would be interesting to see what the AEs and SAEs were reported more frequently in these
studies.
6.  RESULTS -  The authors state: "Regarding the 8 studies with available SAE comparison,
results indicate increased risk  (RRs [95% CIs]) of SAE occurrence with both MDN and SDN
versus control, 1.56 ([0.39; 6.25], P=0.533) and 1.77 ([0.90; 3.49], P=0.100), respectively. The
risk of SAE occurrence in MDN and SDN was similar (RR [95% CI]): 0.88 ([0.19; 4.14],
P=0.871)." These results are not statistically significant at the 95% confidence level, for which
you cannot say there is an increased risk of SAE occurrence. Same when the authors say, "MDN
had a higher benefit-risk ratio compared to SDN [95% CI]: 1.18 ([-0.36; 2.72], P=0.133)."
7.  DISCUSSION- As a general comment, most of the discussion is quite vague and based on
mentioning results from other studies and not related to discussing the results from the present
study.
8. CONCLUSION - Based on the reported results, it is not correct to state that MDN has a
positive benefit-risk ratio compared to SDN (see comment above).
Title: Safety Comparison of Single-Donor and Pooled Fecal Microbiota Transfer Product
Preparation in Ulcerative Colitis: Systematic Review and Meta-Analysis
Version: 2 Date: 29 Jul 2024
Reviewer's report:
Interesting research topic. Some comments.
1.  METHODS -  Search strategy and selection criteria. As stated in this subheading, the the
authors should report the search strategy first in this section and the selection criteria after.
2.  METHODS - It is highly recommended that the literature search is completed within the
last 12 months before submission to ensure the review includes the most up-to-date evidence.
Would suggest updating the search.
3.  METHODS -  Most of the manuscript is a description of the methods. I would suggest
focusing more on results and discussion, which could be improved with more detail, and moving
sections from methods to supplementary materials.
4. RESULTS- Main findings from individual studies. The authors talk about "characteristics of
the 44 eligible studies..."please clarify, there were 44 identified studies, 29 of them excluded
and 15 deemed eligible.
5. RESULTS - Synthesis of results:safety assessment. Given the main goal is to assess safety,
it would be interesting to see what the AEs and SAEs were reported more frequently in these
studies.
6.  RESULTS -  The authors state: "Regarding the 8 studies with available SAE comparison,
results indicate increased risk  (RRs [95% CIs]) of SAE occurrence with both MDN and SDN
versus control, 1.56 ([0.39; 6.25], P=0.533) and 1.77 ([0.90; 3.49], P=0.100), respectively. The
risk of SAE occurrence in MDN and SDN was similar (RR [95% CI]): 0.88 ([0.19; 4.14],
P=0.871)." These results are not statistically significant at the 95% confidence level, for which
you cannot say there is an increased risk of SAE occurrence. Same when the authors say, "MDN
had a higher benefit-risk ratio compared to SDN [95% CI]: 1.18 ([-0.36; 2.72], P=0.133)."
7.  DISCUSSION- As a general comment, most of the discussion is quite vague and based on
mentioning results from other studies and not related to discussing the results from the present
study.
8. CONCLUSION - Based on the reported results, it is not correct to state that MDN has a
positive benefit-risk ratio compared to SDN (see comment above).
Please review this paper.
user
Title: Safety Comparison of Single-Donor and Pooled Fecal Microbiota Transfer Product
Preparation in Ulcerative Colitis: Systematic Review and Meta-Analysis
Version: 2 Date: 29 Jul 2024
Reviewer's report:
Interesting research topic. Some comments.
1.  METHODS -  Search strategy and selection criteria. As stated in this subheading, the the
authors should report the search strategy first in this section and the selection criteria after.
2.  METHODS - It is highly recommended that the literature search is completed within the
last 12 months before submission to ensure the review includes the most up-to-date evidence.
Would suggest updating the search.
3.  METHODS -  Most of the manuscript is a description of the methods. I would suggest
focusing more on results and discussion, which could be improved with more detail, and moving
sections from methods to supplementary materials.
4. RESULTS- Main findings from individual studies. The authors talk about "characteristics of
the 44 eligible studies..."please clarify, there were 44 identified studies, 29 of them excluded
and 15 deemed eligible.
5. RESULTS - Synthesis of results:safety assessment. Given the main goal is to assess safety,
it would be interesting to see what the AEs and SAEs were reported more frequently in these
studies.
6.  RESULTS -  The authors state: "Regarding the 8 studies with available SAE comparison,
results indicate increased risk  (RRs [95% CIs]) of SAE occurrence with both MDN and SDN
versus control, 1.56 ([0.39; 6.25], P=0.533) and 1.77 ([0.90; 3.49], P=0.100), respectively. The
risk of SAE occurrence in MDN and SDN was similar (RR [95% CI]): 0.88 ([0.19; 4.14],
P=0.871)." These results are not statistically significant at the 95% confidence level, for which
you cannot say there is an increased risk of SAE occurrence. Same when the authors say, "MDN
had a higher benefit-risk ratio compared to SDN [95% CI]: 1.18 ([-0.36; 2.72], P=0.133)."
7.  DISCUSSION- As a general comment, most of the discussion is quite vague and based on
mentioning results from other studies and not related to discussing the results from the present
study.
8. CONCLUSION - Based on the reported results, it is not correct to state that MDN has a
positive benefit-risk ratio compared to SDN (see comment above).
assistant