Clinical Trial Results:
FERARO: A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms
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Summary
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EudraCT number |
2019-001618-41 |
Trial protocol |
GB |
Global end of trial date |
25 Oct 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
16 May 2026
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First version publication date |
16 May 2026
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Other versions |
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Summary report(s) |
FERARO CSR 11SEP2024 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FERARO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Guy's and St Thomas NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE1 9RT
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Public contact |
Simon Goldenberg, Guy's and St Thomas' NHS Foundation Trust , 44 207 188 8515, simon.goldenberg@gstt.nhs.uk
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Scientific contact |
Simon Goldenberg, Guy's and St Thomas' NHS Foundation Trust , 44 207 188 8515, simon.goldenberg@gstt.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Oct 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Oct 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Oct 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
A dose finding study evaluating the safety and tolerability of capecitabine + aflibercept in patients with unresectable metastatic colorectal cancer deemed unsuitable for doublet/triplet cytotoxic chemotherapy.
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Protection of trial subjects |
The right of a participant to refuse participation without giving reasons will be respected. The participants remain free to withdraw at any time from the trial without giving reasons and without prejudicing his/her further treatment and will be provided with a contact point where he/she may obtain further information about the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Feb 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
28
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From 65 to 84 years |
16
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
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Pre-assignment period milestones
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Number of subjects started |
124 [1] | |||||||||
Number of subjects completed |
44 | |||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Eligibility not confirmed: 72 | |||||||||
Reason: Number of subjects |
Did not attend baseline appointement: 8 | |||||||||
| Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: We do not count screened participants as enrolled |
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active | |||||||||
Arm description |
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Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Capsulised lyophilised Faecal Microbiota Transplant (FMT)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Size 0 capsules administered orally
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
cellulose encapsulated in size 0 delayed release methylcellulose capsules
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was comprised of microcrystalline cellulose encapsulated in size 0 delayed release methylcellulose capsules (DRcaps™, Capsugel®, Lonza, Livingston, UK).
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Baseline characteristics reporting groups
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Reporting group title |
Active
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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End points reporting groups
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Reporting group title |
Active
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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End point title |
Percentage of approached participants who were screened for active arm [1] [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Duration of the Study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please see uploaded report [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Please see uploaded report |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
SAE reporting 30 days post last treatment dose
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Adverse event reporting additional description |
For the purposes of the FERARO trial, the following hospitalisations are NOT considered SAEs:
• Routine treatment or monitoring of the studied indication, not associated with any
deterioration in condition or trial procedures
• Treatment which was elective or pre-planned, for a pre-existing condit
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
Active
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Jun 2020 |
Updated FMT MIA IMP
In response to a conditional approval. The updated MIA(IMP) was issued on 07 April 2019 and includes authorization of the FMT
lab to manufacture the oral capsules required for the trial. |
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03 Sep 2020 |
Protocol v2.0 + COVID-19 IB and donor PIS
Protocol v2.0 update, IMPD corrections, IB V2.0, Donor stool sample information sheet update, and Donor Information Sheet update |
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03 Dec 2020 |
IMPD - IMP Shelf Life extension |
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28 Nov 2021 |
Protocol v3.0 and PIS v1.2
Main changes are related to primary endpoint wording and eligibility criteria |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| 80 participants planned for recruitment. Only 44 randomised due to eligibility being not confirmed, not attending baseline appointments, and COVID and manufacturing delays. | |||
