Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients Post-intestinal Anastomosis
Conditions: Abdominal Surgery
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Version 2. 19th September, 2025 
ANALYSIS OF THE COMPOSITION OF THE INTESTINAL MICROBIOTA AND ITS EVOLUTION 
IN PATIENTS POST–INTESTINAL ANASTOMOSIS 
Protocol Code: MIDESIN 
Version 2, September 19, 2025 
Dr. Mariano García Arranz 
Laboratory of New Surgical Therapies 
IIS–FJD 
Ethics Committee Code: PIC165-25_FJD 
 
SUMMARY 
Study Identification 
Title: “Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients 
Post–Intestinal Anastomosis” 
Code: MIDESIN 
Version: 1, July 22, 2025 
Study Sites 
The study will be conducted at the Hospital Universitario Fundación Jiménez Díaz and the 
Instituto de Investigación Sanitaria Fundación Jiménez Díaz. 
Ethics Committee 
The study will be submitted to the CEI/CEIm of the Hospital Universitario Fundación 
Jiménez Díaz. A 
Ethics Committee Code: PIC165-25_FJD 
Approved: 2025, 19th September 
Hypothesis 
Considering natural interindividual variability, the scientific literature suggests that specific 
microbiological patterns may exist among patients with colorectal cancer. Our primary 
hypothesis is that within this patient population, the colorectal microbiota differs between 
patients who develop postoperative anastomotic leakage and those who do not experience 
postoperative complications. 

Version 2. 19th September, 2025 
Objectives 
Primary Objective 
To characterize the microbiome of patients undergoing colorectal surgery and evaluate the 
impact of current surgical preparation on the microbiota of the local population. 
Secondary Objectives 
- Classification and prediction of postoperative evolution in patients undergoing colorectal 
anastomosis, through metagenomic characterization of the intestinal microbiota. 
- Analyze the relationship between intestinal microbiota and its potential involvement in 
postoperative anastomotic leaks. 
Study Design 
Prospective, descriptive, non-interventional research project in which some variables will 
be analyzed cross-sectionally. 
Condition Under Study 
Any type of intestinal surgery in which an intestinal anastomosis is performed. 
Study Population and Sample Size 
A total of 30 patients requiring colorectal anastomosis surgery and meeting the 
inclusion/exclusion criteria will be enrolled. 
Timeline 
Start: December 2025 
Recruitment: 12 months 
Follow-up: 1 month per patient 
Total duration: 13 months (until December 2026) 
Additional time: 3 months for sample analysis + 1 month for result review. 
 
 
 
 
 

Version 2. 19th September, 2025 
PROTOCOL 
 
INTRODUCTION AND STUDY RATIONALE 
Recent investigations suggest a significant relationship between the intestinal microbiota 
and anastomotic leakage (AL) in colorectal surgery. Patients with AL exhibit greater 
abundance of Lachnospiraceae bacteria and reduced microbial diversity. Factors shaping 
the microbiota profile include preoperative interventions and surgical variables. 
Further evidence regarding the role of microbiota in AL largely comes from animal studies, 
with limited understanding in surgical patients. Perioperative factors such as diet, radiation, 
bowel preparation, and medications have been linked to microbiota alterations and 
increased AL risk. Mechanisms include bacterial adhesion to intestinal mucosa, biofilm 
formation, and impaired host resistance. 
Previous studies also describe involvement of Enterococcus faecalis and Bifidobacterium 
spp. in AL. 
Given the existing data, our objective is to analyze the microbiota of our patient population 
and subsequently identify microbiome differences between those who develop an 
anastomotic leak (approximately 9–10%) and those who do not. 
REFERENCES 
-Van Praagh JB  et al. Intestinal microbiota and anastomotic leakage of stapled colorectal 
anastomoses: a pilot study. Surg Endosc. 2016;30(6):2259-65.   
-Liu, Y et al. New understanding of gut microbiota and colorectal anastomosis leak: A 
collaborative review of the current concepts. Front Cell Infect Microbiol 2022, 
1:12:1022603.   
-Hajjar, R et al. Current evidence on the relation between gut microbiota and intestinal 
anastomotic leak in colorectal surgery. Am J Surg  2019;218(5):1000-1007.   
-Boatman, S et al. The Influence of the Microbiome on Anastomotic Leak. Clin Colon Rectal 
Surg  2023;36(2):127-132.   
- Shogan, BD et al. Collagen degradation and MMP9 activation by Enterococcus faecalis 
contribute to intestinal anastomotic leak. Sci Transl Med 2015;7(286):286ra68.   
-Mima, K et al. Mucosal cancer-associated microbes and anastomotic leakage after resection 
of colorectal carcinoma. Surg Oncol 2020:32:63-68 
 
STUDY HYPOTHESIS AND OBJECTIVES 

Version 2. 19th September, 2025 
Hypothesis 
The colorectal microbiota differs between patients with postoperative anastomotic leakage 
and those without complications. 
Primary Objective 
To characterize the microbiome of patients undergoing colorectal surgery and evaluate the 
effects of current surgical preparation. 
Secondary Objectives 
- Classification and predictive indication of postoperative outcomes in colorectal 
anastomosis patients using metagenomic characterization. 
- Identify preliminary indications of links between intestinal microbiota and postoperative 
anastomotic leaks. 
STUDY TYPE AND DESIGN 
Prospective, descriptive, non-interventional project. 
SUBJECT SELECTION 
Patients will be selected from individuals undergoing abdominal surgery requiring 
colorectal anastomosis. Eligible patients will be invited to participate and assigned coded 
identifiers. 
Inclusion Criteria: 
- Undergoing colorectal anastomosis 
- Signed informed consent 
- Age ≥18 years 
- Availability for postoperative follow-up 
Exclusion Criteria: 
- Emergency surgery 
- Intra-abdominal sepsis or prior leaks 
- Severe immunosuppression 
- Antibiotic use within 3 months 
- Pregnancy or breastfeeding 

Version 2. 19th September, 2025 
STUDY DEVELOPMENT AND OUTCOME EVALUATION 
Phase I – Ethics approval 
Phase II – Patient selection, consent, coding 
Phase III – Sample collection using GutAlive® kits 
Phase IV – Sample processing at MicroViable Therapeutics 
Phase V – Bioinformatic and clinical outcome analysis 
 
SEQUENCING PROTOCOL 
The project presented will be developed according to the following phases: 
- Phase I. Authorization of the trial by the HUFJD Ethics Committee. 
- Phase II. Selection of patients by the Surgery team and signing of the informed consent 
form by the patients. Once the patient has been included in the study, they will be coded so 
that only the two people involved in this procedure from the research team can associate 
the medical record number with the code. This code will be marked on the GutAlive® 
devices using labels that are resistant to deep freezing. 
- Phase III. Sample collection: Patients will be given three GutAlive® kits, and one kit will be 
given to the surgical team.  
GutAlive® is an anaerobic stool collection device that guarantees sample stability and 
microbiota viability, preserving its original composition and diversity by creating an 
anaerobic atmosphere inside. It also preserves DNA integrity thanks to the viability of the 
bacterial cells. It is currently the stool collection system included in the protocols of the 
Spanish Association of Gastroenterology for Fecal Microbiota Transplant procedures.  
- Once the samples have been collected by the patients, they will be sent to the IIS-FJD New 
Therapies Laboratory within 48 hours of collection. Samples received at the New Therapies 
Laboratory will be stored in the GutAlive® device, frozen at -80°C, until they are processed. 
This coding will be marked on the GutAlive® devices using labels that are resistant to ultra-
freezing. 
- Phase IV. Sample processing. The collected and coded samples will be transported 
refrigerated to MicroViable Therapeutics, using dry ice to prevent them from thawing. At 
Microviable, the bacterial DNA will be extracted from the samples and massively sequenced 
using Illumina technology. Subsequently, also at Microviable, the metagenomic and 
statistical bioinformatic analysis of the sequencing data will be carried out (see protocol). 
- Phase V. Analysis of results. Once the coded metagenomic results have been obtained, the 
research team will compare the clinical evolution of the patients in an anonymized manner 
with these results and then extract patterns from the microbiota of the study population. To 

Version 2. 19th September, 2025 
handle large amounts of data, we have a cloud computing platform with unlimited 
processing capacity that also guarantees data security. 
Protocol Sequencing and analysis of the microbiota present in the samples 
1.    Collection of a stool sample using the GutAlive® device 
(https://www.microviable.com/gutalive), which facilitates, sanitizes, and standardizes 
sample collection.  
2.    Storage and anonymization of samples in the advanced therapies laboratory of the 
Jiménez Díaz Foundation's Health Research Institute. 
2.    Shipping and processing of anonymized samples to MicroViable Therapeutics facilities. 
3.    Extraction of total DNA from samples using commercial kits such as: DNeasy PowerSoil 
Pro Kit (Qiagen) for the extraction of microbial DNA from stool samples. 
4.    Quantification of DNA using the Qubit dsDNA BR Assay kit. 
5.    Creation of libraries and DNA sequencing using NGS with Illumina technology, 2x300 
bp, paired reads, 20-50 million reads per sample. 
6.    Response evaluation. 
VARIABLES AND OUTCOME EVALUATION 
Patient-Related Variables: 
- Postoperative clinical evolution (1 month) 
- Clinically or surgically diagnosed anastomotic leaks 
Sample-Related Variables: 
- Bacterial sequence comparison 
- Taxonomy and abundance 
Outcome Evaluation: 
- Microbiota characterization 
- Association between taxonomy and clinical evolution 
- Preliminary indications regarding anastomotic leaks 
PRIMARY ANALYSIS 
Bioinformatic analysis of sequencing results, including: 

Version 2. 19th September, 2025 
- Quality analysis with barcode and sequence filtering. 
- Taxonomic identification of microorganisms at the phylum, order, class, family, genus, and 
species levels through comparison with databases. 
- Quantification of relative abundance for each identified bacterial taxon. 
-    Alpha diversity analysis using different indices (Shannon, Simpson, Fisher, Observed 
OTUs) 
- Beta diversity analysis using different indices and matrices (Bray-Curtis, Jaccard, UniFrac), 
representation of figures (PCoA, NMDS, etc.) and comparison between groups. 
• Statistical analysis using specific algorithms such as ANCOM, Simper, Adonis, Anosim, 
PERMANOVA, and others. 
- Identification of metabolic pathways predicting the functionality of the microbiota. 
- Calculation of relative abundances of each identified metabolic pathway. 
- Statistical analysis of the differential presence of metabolic pathways using specific 
algorithms (Maaslin2 and LEFSE) 
    Assignment of metabolic pathways to the corresponding microbial groups 
BIOLOGICAL SAMPLES 
Four GutAlive® samples per patient: 
1. Before surgical preparation 
2. Intraoperative 
3. At discharge (~day 5) 
4. 1-month follow-up 
 
ADVERSE EVENT MANAGEMENT 
No adverse events expected. 
ETHICAL CONSIDERATIONS 
Compliance with the Declaration of Helsinki, GCP, GDPR, Spanish data protection law. Coded 
database. No insurance required. 
PRACTICAL CONSIDERATIONS 

Version 2. 19th September, 2025 
GCP compliance, data recording procedures, patient rights, data retention for 10 years. 
The information disseminated and obtained through the implementation of this project is 
considered confidential and will be treated at all times in accordance with current data 
protection regulations (Regulation (EU) 2016/679 of the European Parliament and of the 
Council of April 27, 2016, on Data Protection (GDPR), on the Protection of Personal Data, 
and Organic Law 03/2018 on Data Protection). An Excel database will be created 
specifically for the study, in which patients will be identified with a binary code (letter-
number) assigned in order of recruitment, and which will not contain any personal 
information about the patients. 
STATISTICAL ANALYSIS 
Sample Size 
Based on AL incidence (9–10%), n=30 deemed sufficient. 
Statistical Methods 
Statistical analysis of microbiota correlations and clinical evolution 
All statistical comparisons will be made taking into account the grouping of patients 
according to their clinical evolution, for which a matrix of possible comparisons will be 
made based on the clinical metadata provided by researchers at the Jiménez Diaz 
Foundation. 
Both longitudinal analyses, which will allow us to see the temporal evolution of the patients' 
microbiota and how surgical preparation influences it, and cross-sectional analyses will be 
performed, taking into account variables related to the incidence of dehiscence and the 
clinical evolution of each group of patients, in search of intestinal microbiota parameters 
that serve as biomarkers to predict suture failure after surgery.  
These analyses will be performed using the R-studio statistical packages for Windows 11 
and include, among others, the following packages: dplyr, ggplot2, ggpubr, pheatmap, 
readxl, RColorBrewer, remotes, stringi, stringr, tibble, tidyr, vegan, ANCOM-BC, Maaslin2, 
microbiome, microbiomeMarker, phyloseq, and Adonis.STUDY PUBLICATION 
Results will be published and made publicly available, following ethical obligations. 
 
 
 
 
 

Version 2. 19th September, 2025 
 
PARTICIPANT INFORMATION SHEET 
 
PROJECT TITLE: Analysis of the composition of the intestinal microbiota and its evolution in 
post–intestinal anastomosis patients 
PROJECT CODE: MIDESIN 
PRINCIPAL INVESTIGATOR: Dr. Mariano García Arranz, New Therapies Laboratory / 
Surgery. Fundación Jiménez Díaz Health Research Institute. 
Ethical committee approved Code: PIC165-25_FJD (2025, 19th September) 
 
INTRODUCTION 
We are writing to inform you about a research study in which you are invited to participate. 
The study has been approved by the corresponding Clinical Research Ethics Committee in 
accordance with current legislation and complies with the principles set out in Biomedical 
Research Law 14/2007 and the Declaration of Helsinki in its most recent update (75th 
World Medical Assembly, held in Helsinki in October 2024). 
Our intention is that you receive accurate and sufficient information so that you can decide 
whether or not you wish to participate in this study. To this end, please read this 
information sheet carefully; afterwards, we will clarify any questions that may arise. You 
may also consult with anyone you consider appropriate. Please be informed that this work 
is an independent initiative of the study investigators, has public funding for its execution, 
and the participating investigators will not receive any financial compensation. 
OBJECTIVE OF THE STUDY 
The rationale for proposing this study is based on recent research suggesting a relationship 
between the intestinal microbiota and anastomotic leakage (dehiscence) in colorectal 
surgery. Patients who develop leaks show a greater abundance of intestinal bacteria from 
the families Lachnospiraceae, Enterococcaceae, and Bifidobacteriaceae, as well as lower 
microbial diversity. In addition, various perioperative factors influencing bacterial diversity 
have been described and linked to a higher risk of post-surgical dehiscence. Therefore, 
considering the available literature, our main interest is to analyze the composition of the 
intestinal microbiotaí to analyze the composition of the intestinal microbiota of patients in 
our social environment and subsequently look for differences at the microbiota level 
between those who have experienced an anastomotic dehiscence and those who have not. 

Version 2. 19th September, 2025 
The primary objective of this study is to determine the composition of the intestinal 
microbiota (defined as the set of microorganisms residing in our intestine) and the effect 
that current surgical preparation has on it in the population of our environment. 
Likewise, a secondary objective is to carry out a taxonomic classification of the bacteria 
present in the intestinal microbiota to determine which bacteria are present and in what 
proportion or abundance. This will generate data to support future studies involving a 
larger number of patients and to help predict the likelihood of suture dehiscence associated 
with postoperative evolution in patients undergoing colorectal anastomosis surgery. 
DESCRIPTION OF THE STUDY 
This study involves the collection of stool samples at four key time points for analysis: 
1. 
Before the intestinal preparation recommended prior to surgery, 
2. 
On the day of surgery, 
3. 
5–7 days after surgery, and 
4. 
At the one-month postoperative follow-up visit. 
You will be provided with three GutAlive® kits. On the day of surgery, your surgeon will 
collect the sample. GutAlive® is a stool collection device (container) that ensures sample 
stability while preserving its original composition and diversity. The sample should be kept 
at room temperature and sent or delivered to the New Therapies Laboratory at Fundación 
Jiménez Díaz within a maximum of 48 hours after collection. To do so, you should contact 
phone number 915 504 800, extension 3398 (Dr. Mariano García Arranz). GutAlive® is 
currently the stool collection system included in the protocols of the Spanish Association of 
Gastroenterology for Fecal Microbiota Transplant procedures. 
Once the samples are received at the laboratory, they will be stored inside the GutAlive® 
device, frozen at −80°C, until processing. At this point, the samples will be coded using four 
associated digits (PnºMnº, where P = patient and M = sample collected). For example, P1-
M1 would be patient 1, first sample; P1-M2 would be patient 1, second sample, and so on. 
This coding will be labeled on the GutAlive® devices using labels resistant to ultra-freezing. 
Subsequently, the collected samples will be transferred to the company Microviable 
Therapeutics, where high-resolution microbiota analysis will be performed using next-
generation sequencing and advanced bioinformatic (metagenomic) analysis. Likewise, 
periodic meetings will be held between the New Therapies Laboratory of IIS-FJD and the 
clinical team to collect, in an anonymized manner, data on clinical outcomes associated with 
your treatment during the first 30 days after surgery. 
Finally, once the coded metagenomic results have been obtained, the research team will 
compare the clinical evolution of patients, in a coded manner, with these results and 
subsequently extract microbiota patterns from the study population. To manage large 

Version 2. 19th September, 2025 
volumes of data, we use a cloud computing platform with unlimited processing capacity that 
also guarantees data security. 
STUDY ACTIVITIES 
Once you have signed the informed consent, your physician will carry out the usual tests 
proposed for your treatment outside the study. During this visit, you may ask the specialist 
any questions and you will be asked to authorize the selected procedure. 
If you meet the criteria to participate in the study and give your approval, you will be 
included and provided with a GutAlive® device to collect your stool at home, always before 
starting the intestinal preparation recommended prior to surgery. Once collected, the 
sample should be kept at room temperature according to the GutAlive® system instructions 
and sent to the hospital within a maximum of 48 hours after bowel movement. These 
samples will be coded and stored by members of the New Therapies Laboratory. 
On the day of surgery, the responsible surgeon, who is also a member of the research team, 
will collect any fecal content present in the colon during the procedure and transfer it to the 
New Therapies Laboratory for coding and storage. Upon hospital discharge or at the first 
follow-up visit (between days 5–7), you will be asked to collect another sample. Finally, one 
month after surgery, you will be asked for an additional sample. For this purpose, you will 
be provided with two additional GutAlive® devices upon discharge. 
It is expected that the proposed sample collection will not extend your hospital stay or alter 
the usual tests or treatment process. Otherwise, you will continue with treatment and 
follow-up as determined by your physician. Please consult the study physician before taking 
any prescription or over-the-counter medication until the last stool sample associated with 
the study has been collected. 
You should be aware that you may be excluded from the study if the investigators consider 
it appropriate, either for safety reasons (e.g., your condition does not respond adequately, 
any adverse event that may alter the intestinal microbiota, etc.) or because they consider 
that you are not complying with established procedures. In any case, you will receive an 
appropriate explanation for the reason for your withdrawal from the study. 
By signing the attached consent form, you agree to comply with the study procedures 
described above. 
WHAT WILL HAPPEN IF YOU DECIDE NOT TO PARTICIPATE IN THIS STUDY? 
Your participation in this study is completely voluntary. You may refuse to participate or 
withdraw from the study at any time. This will not affect in any way the care you receive or 
your relationship with your physician. In addition, the study physician may decide to 
discontinue your participation (for example, if they believe it is better for you not to 
participate or if you fail to comply with necessary procedures). If this occurs, you will 
receive an appropriate explanation. 

Version 2. 19th September, 2025 
BIOLOGICAL SAMPLES / GENETIC ANALYSES 
Possibility of unexpected findings 
When analyzing your samples, information with implications for your health may be 
obtained, including unexpected findings, which you have the right to know if you so wish. 
You may indicate your preference at the end of this document. If you decide to be informed 
and the information also has implications for your biological relatives, you are advised to 
inform them personally. In any case, you should be aware that, as required by regulations, if 
the information is deemed by the responsible physician to be necessary to avoid serious 
harm to your health or that of your biological relatives, a close family member or 
representative will be informed, after consultation with the hospital’s Healthcare Ethics 
Committee (CEAS). 
Fate of the sample after use in this research project 
Once the research is completed, surplus samples may remain. In this case, Microviable will 
handle the coded samples according to your authorization. You are offered the following 
options: 
• 
Destruction of the surplus sample. 
• 
Storage for future research use, in accordance with applicable legislation: 
o 
FJD Biobank, Registration No. B.0000647 (if deposited in a biobank, the scope of use 
will be defined by what you have accepted in the informed consent document for transfer to 
the biobank, including the clause for donation of research surplus to the FJD Biobank). 
BENEFITS AND RISKS OF PARTICIPATION 
You are unlikely to benefit directly from participating in this study. However, we hope that 
the results will contribute to a better understanding of the effect of the microbiota on 
anastomotic dehiscence. Your participation does not involve any risk, as there are no 
extraordinary clinical tests other than stool collection. You will be informed if any relevant 
information arises during the study that could affect your continued participation. 
All procedures related to this study are non-invasive and consist solely of four stool 
collections over the one-month study period. 
ECONOMIC ASPECTS 
This is a non-profit study that does not have direct funding; however, an agreement has 
been reached with Microviable to process the samples based on scientific interest. Neither 
the investigators nor the center receive any financial compensation for participating. Your 
participation will not incur any costs, nor will you receive financial compensation. 
 

Version 2. 19th September, 2025 
CONFIDENTIALITY AND DATA PROTECTION 
Data Controller 
Both the center where the clinical research is conducted and the Sponsor are responsible 
for processing your personal data, each fulfilling their respective obligations under data 
protection regulations. 
The center where the research is conducted processes the data obtained, including clinical 
history data when applicable, for the purpose of conducting the research. For any issues 
related to data processing, you may contact our DPO at DPO@fjd.es. 
The Sponsor is also responsible for processing the data generated in the research but will 
only process coded data and therefore will not know your identity. For any data protection 
queries, you may also contact DPO@fjd.es. 
Legal basis for data processing 
The legal basis is compliance with legal obligations under biomedical research regulations, 
based on the general interest in scientific research and the improvement and assurance of 
quality and safety once informed consent has been given. 
Purposes of data processing 
• 
Promotion and quality of biomedical research 
• 
Monitoring and control of research studies 
• 
Inspections and control measures 
• 
Evaluation of participants’ health status 
• 
Obligation to report research results 
• 
Reuse of data for related research areas 
Coding process 
The Sponsor accesses only coded data. Coding is performed by the research team, 
specifically by Dr. Rocío Olivera Salazar of the IIS-FJD New Therapies Laboratory, by 
assigning each participant a unique alphanumeric code. The link between the code and 
participant identity is securely and confidentially retained exclusively by the IIS-FJD 
research team. 
Who has access to your data? 
Access may be granted to the Principal Investigator and their team, CROs (if applicable), 
monitors, auditors, and other service providers involved in the research, all under 
confidentiality obligations. 

Version 2. 19th September, 2025 
Data disclosure 
Data may be disclosed to Ethics Committees and Health Authorities as required by law, and 
in the event of adverse reactions, to health authorities and insurance companies. 
Retention 
Data will be retained during the study and for up to five years thereafter to comply with 
regulatory obligations. 
Rights 
You have the right to access, rectify, delete, or restrict processing of your data, subject to 
legal limitations. To exercise these rights, contact the Principal Investigator with the 
reference “data protection rights,” providing identification and specifying the right you wish 
to exercise. You may also file a complaint with the competent supervisory authority. 
PUBLICATION OF RESULTS 
The results of this study will be made public through channels accepted by the scientific 
community, always maintaining participant confidentiality. No identifying data will be 
published. 
________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 2. 19th September, 2025 
WRITTEN INFORMED CONSENT FOR THE PATIENT 
PROJECT TITLE: Analysis of the composition of the intestinal microbiota and its evolution in 
post–intestinal anastomosis patients 
PROJECT CODE: MIDESIN 
PRINCIPAL INVESTIGATOR: Dr. Mariano García Arranz, New Therapies Laboratory / 
Surgery. Fundación Jiménez Díaz Health Research Institute. 
Ethical committee approved Code: PIC165-25_FJD (2025, 19th September) 
I, …………………………………………………………………………………., 
declare that: 
• 
Dr. …………………………………………………………… has informed me about this study 
• 
I am of legal age 
• 
I have read the information sheet provided to me 
• 
I have been able to ask questions about the study 
• 
I have received satisfactory answers 
• 
I have received sufficient information 
• 
I understand that my participation is voluntary 
• 
I understand that I may withdraw from the study at any time, without explanation 
and without affecting my medical care 
• 
I freely consent to participate in the study 
• 
I understand that analysis of my samples may reveal health-related information, 
including unexpected findings. 
o 
I wish to be informed ____ I do not wish to be informed ____ 
• 
If surplus samples remain, I acknowledge having been informed of the available 
options: 
o 
I request destruction of the surplus sample ____ 
o 
I request storage in an authorized biobank for future research use under the 
conditions explained 
o 
Transfer to the FJD Biobank 

Version 2. 19th September, 2025 
 
In Madrid, on …… of ……………………………, 20…… 
 
Name and Signature of the Participant 
Date   
 
Name and Signature of the Investigator 
Date