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

NCT04222153 | Completed

• 1 other identifier: FMT01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Chronic Kidney Diseases

Keywords

Fecal Microbiota Transplantation (FMT); Gut microbiota; Uremic toxins

Outcome Measures

Primary Outcomes (1)

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

  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): 1. Preliminary interview - anamnestic interview to exclude people with history of disease and risk factors 2. Secondary interview - anamnestic interview (on the day of donation) to exclude donors with recently appeared harmful issues 3. 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.

  2 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed by healthy volunteers, aged between 18 and 50, with normal BMI and characterized by omnivorous diet.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• University of Bari Aldo Moro: collaborator

Study Sites (1)

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Loreto Gesualdo, MD Full Prof

  Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: January 9, 2020
• Study Start: November 26, 2019
• Primary Completion: February 26, 2020
• Study Completion: December 26, 2021
• Last Updated: February 8, 2023

Record last verified: 2020-01

Locations

IT (1)