Innovative Approach to Fecal Microbiota Transplantation (FMT) Applied for Chronic Kidney Disease (CKD)

The aim of this PhD project focuses on the relationship between intestinal microbiota and health in the background of Chronic Kidney Disease (CKD). Many pathologies, including the CKD, display a dysbiosis of the intestinal microbiota, which is at the same time a consequence of CKD and contributes to its progression and complication. In a variety of chronic-degenerative and infectious diseases, the "fecal microbiota transplantation" (FMT) is being tested in recent years in addition with the application of both probiotics and prebiotics. FMT is indeed currently successfully used in the eradication of recurrent Clostridium difficile infections, with success rates of 90%, thus recent evidence suggests that FMT could be applied in other diseases characterized by microbiota dysbiosis, such as CKD and diabetes, in which the FMT has never been previously tested.

This project will allow to study:

i) the prototypal production of the encapsulated suspension of healthy microbiota tested in a minimally invasive FMT procedure (by oral administration);

ii) the efficacy of the innovative prototype for colonization and modulation of intestinal microbiota following FMT;

iii) the experimental and clinical feedback of this suspension, by in vivo studies.

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Key information

Conditions

Healthy Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

About this study

This project will allow to experiment the Fecal microbiota transplantation in the CKD model and to set up a pharmaceutical formulation of fecal suspensions of microbiota.

Firstly, a collection of fecal samples from healthy volunteers will be set up, with the aim to collect biological samples. Screening and enrollment of healthy volunteers, gathering personal and clinical information together with eating habits, will be performed.

The best product design in efficacy, stability over time as well as suitable excipients and any other active components able to perform a synergistic action will be evaluated. After defining the pharmaceutical formulation, the production of the prototype will be finalized.

In a second time in vivo studies on a model of CKD (uremic mouse with CKD induced by 5/6 nephrectomy) will be designed and carried on. The CKD model will be used to evaluate the effects and the outcomes of FMT on clinical parameters such as renal function, circulating levels of uremic toxins, state and function of the intestinal microbiota, intestinal permeability and microbiota composition. This step will be necessary to establish the efficacy of the innovative prototype for the colonization and the modulation of intestinal microbiota following FMT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Criteria: Healthy volunteers

Inclusion criteria

Healthy subjects
Aged between 18 and 50
BMI between 18.5-25
Omnivorous diet
Informed consent signed

Exclusion criteria

Health workers (to exclude the risk of transmission of multi-resistant organisms)
Type 2 diabetes mellitus
Hypertension
Chronic liver disease
Chronic gastrointestinal disorders
Systemic inflammatory disorders
Suspected, clinical diagnosis or previous history of malignancies (<5 years)
Therapies with corticosteroids or immunosuppressive drugs
Autoimmune disorders
Previous history of organ / tissue transplantation
Prior gastrointestinal surgery (eg gastric bypass)
eGFR lower than 60ml / minute and / or diagnosis of nephropathy
Previous acute major cardiovascular diseases (myocardial infarction, stroke)
History of C. difficile infections
Known systemic infection not controlled
Previous use of antibiotics (<3 months)
Recent appearance of diarrhea
Chronic use of laxatives or chronic diarrhea
Chronic constipation
Recurrent urinary tract infections (3 cases per year)
Use of proton pump inhibitors in the last 3 months
Recent use of probiotics or other aids (drugs / supplements) for the regulation of gastrointestinal activity (<3 months)
Pregnancy and breastfeeding
Psychiatric conditions that reduce compliance

Treatment and study plan

Primary outcomes

Number of healthy volunteers enrolled according to the procedures of the FMT01 protocol

Time frame: 2 months
A final number of 10 healthy volunteers will be selected to collect their fecal samples, according to the protocol FMT01 (ref. Cammarota G et al. Gut 2017 doi:10.1136/gutjnl-2016-313017):
- Preliminary interview - anamnestic interview to exclude people with history of disease and risk factors
- Secondary interview - anamnestic interview (on the day of donation) to exclude donors with recently appeared harmful issues
- Sample collection - blood and stool testing to verify the presence of potentially transmittable disease: Cytomegalovirus, Epstein-Barr virus, Hepatitis A, HBV, HCV, Syphilis, HIV-1 and HIV-2, Faecal Helicobacter pylori, Faecal occult blood testing, Fecal ova and parasites Steps 1 and 2 will be analyzed by the physician in order to exclude people, after enrollment, at risk of potential harmful issues. People passing steps 1 and 2 will undergo blood and fecal laboratory screening. Positivity to one or more of the tested factor will result in volunteer exclusion.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

University of Bari Aldo Moro

Registry information

Official study title

Approccio Innovativo di Trapianto di Microbiota Fecale Applicato Alla Malattia Renale Cronica

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Jan 9, 2020
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed