Chronic Kidney Disease Due to HypertensionNCT04361097

Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease

A study testing Faecal microbiota transplant in people with Chronic Kidney Disease Due to Hypertension and Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

What the investigators want to achieve with the protocol is to identify the impact of intestinal microbiota transplantation on the progression of chronic kidney disease. Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD Methodological design: Experimental… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease Due to Hypertension, Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
What is being tested?: Faecal microbiota transplant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteMexico
Study dates: 7 Aug 2018to 21 Apr 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be diagnosed with CKD and creatinine clearance less than 60 ml / minute secondary to hypertension and / or diabetes.
Age over 18 years

Who cannot join

Malignant neoplasms whose last treatment was less than 5 years
Having received antibiotics for any reason during the month prior to enrollment
Have received probiotics in the last 3 months
Have been diagnosed with Clostridium difficile infection in the last year
Have been previously submitted to TMF
Having presented ERC exacerbations during the 3 months prior or present at the time of enrollment

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

What the investigators want to achieve with the protocol is to identify the impact of intestinal microbiota transplantation on the progression of chronic kidney disease.

Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD Methodological design: Experimental, prospective, double-blind. Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60 mL/minute secondary hypertension and/or diabetes and older than 18 years

Read the detailed description

What the investigators want to achieve with the protocol is to identify that impact has transplantation intestinal microbiota on the progression of chronic kidney disease

A.-Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD.

B.-Specific objectives: Evaluate whether decreases TMF markers of inflammation in patients with CKD after being treated with TMF, evaluate the behavior in CKD progression markers in patients undergoing TMF, evaluate the change in bowel microbioma CKD patients before and after undergoing TMF.

C.-Methodological design: Experimental, prospective, double-blind.

D.-Type of study: Controlled clinical trial

E.- Population in study:

-Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60 mL/minute secondary hypertension and/or diabetes, older than 18 years.
- Exclusion Criteria: Malignancies whose last treatment has been less than 5 years, he is receiving antibiotics for any reason during the month prior to enrollment, having received probiotics in the last 3 months, it has been diagnosed with Clostridium difficile infection in the last year, it has been previously subjected to TMF , exacerbations of submitting ERC during the 3 months prior or present at the time of enrollment.
-Criteria for elimination: Failure to comply in the structured patient monitoring, nondelivery of stool samples at set times, the patient decides to no longer participate in the study.

F.- Desing Description: After being selected and randomized patients who meet the criteria for inclusion and exclusion, they are assigned to a group to start treatment TMF (capsules intestinal microbiota frozen) or a group receive placebo capsules which shall consist of an excipient harmless to the body (capsules frozen saline), both will be developed in the service Infectología.

Both groups receive frozen for ingestion orally capsules (comprised of TMF or placebo according to the randomization) with a frequency of 15 capsules each 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule must be ingested over a period no longer than 1 hour.

measurements characteristic factors of the progression of kidney disease day 0,10, 30, 60, 90, 120 and 180 be made consisting of:

Proteins in urine 24 hours
Creatinine clearance 24 hours
CBC
serum creatinine
Urea Nitrogen
Urea
Glucose
Uric acid
IS
venous gases

Blood samples were taken by puncture of peripheral vein by laboratory personnel to assess renal function, urine samples will be collected by the patient at home and transported to the laboratory, none of these samples will be used for genetic analysis , only samples of faeces they underwent genomic analysis, collection of stool samples will days 0, 5, 10 30, 90 and 180 (on 10, 30, 90 and 180 with a range of +/- 2 days).

adverse effects questionnaires on days 1, 5, 30 and 60 is performed and quality of life assessment on days 0, 10, 30, 90 and 180.

Monitoring will face on a weekly basis to register if they have submitted infections, adverse effects and whether changes have received treatment. Visits will be made in the epidemiology and the Regional Center for Kidney Diseases University Hospital

Conditions: Chronic Kidney Disease Due to Hypertension, Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
Being tested: Faecal microbiota transplant, Placebo
Keywords: chronic kidney disease, fecal microbiota
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Faecal microbiota transplantBiological
Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
PlaceboBiological
Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.

Study groups in NCT04361097
Study group	Role	What they receive
Faecal microbiota transplant	Experimental	This group will receive frozen capsules to be ingested orally constituted of TMF with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour. Receives: Biological: Faecal microbiota transplant
Placebo	Placebo comparator	This group will receive frozen capsules to be ingested orally placebo with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Creatinine Clearance
Arrest CKD progression
Measured: 6 months

Secondary outcomes (21)

24-hour Urine Protein
Arrest CKD progression
Measured: 6 months
Serum Creatinine
Arrest CKD progression
Measured: 6 months
Hemoglobin
Arrest CKD progression
Measured: 6 months
Hematocrit
Arrest CKD progression
Measured: 6 months
Leukocytes
Arrest CKD progression
Measured: 6 months
Neutrophils
Arrest CKD progression
Measured: 6 months
Platelets
Arrest CKD progression
Measured: 6 months
Glucose
Arrest CKD progression
Measured: 6 months
Urea Nitrogen
Arrest CKD progression
Measured: 6 months
Uric Acid
Arrest CKD progression
Measured: 6 months
Albumin
Arrest CKD progression
Measured: 6 months
Reactive Protein C
Arrest CKD progression
Measured: 6 months
Chlorine
Arrest CKD progression
Measured: 6 months
Sodium
Arrest CKD progression
Measured: 6 months
Potassium
Arrest CKD progression
Measured: 6 months
Phosphorous
Arrest CKD progression
Measured: 6 months
pH Venous Gasometry
Arrest CKD progression
Measured: 6 months
CO2 pressure venous
Arrest CKD progression
Measured: 6 months
Venous Bicarbonate
Arrest CKD progression
Measured: 6 months
Base Excess
Arrest CKD progression
Measured: 6 months
Lactate
Arrest CKD progression
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201821 Apr 2020

First posted24 Apr 2020
Study start7 Aug 2018
Primary completion7 Nov 2019
Study completion21 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney Disease Due to HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, double blind, experimental
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04361097
Sponsor's protocol ID: IF18-00003
Status last verified: Apr 2020
First submitted: 22 Apr 2020
Last updated: 28 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Choi HH, Cho YS. Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives. Clin Endosc. 2016 May;49(3):257-65. doi: 10.5946/ce.2015.117. Epub 2016 Mar 9.
PubMed 26956193
Cruz-Mora J, Martinez-Hernandez NE, Martin del Campo-Lopez F, Viramontes-Horner D, Vizmanos-Lamotte B, Munoz-Valle JF, Garcia-Garcia G, Parra-Rojas I, Castro-Alarcon N. Effects of a symbiotic on gut microbiota in Mexican patients with end-stage renal disease. J Ren Nutr. 2014 Sep;24(5):330-5. doi: 10.1053/j.jrn.2014.05.006. Epub 2014 Jul 22.
PubMed 25066654
Felizardo RJ, Castoldi A, Andrade-Oliveira V, Camara NO. The microbiota and chronic kidney diseases: a double-edged sword. Clin Transl Immunology. 2016 Jun 10;5(6):e86. doi: 10.1038/cti.2016.36. eCollection 2016 Jun.
PubMed 27757226
Guida B, Germano R, Trio R, Russo D, Memoli B, Grumetto L, Barbato F, Cataldi M. Effect of short-term synbiotic treatment on plasma p-cresol levels in patients with chronic renal failure: a randomized clinical trial. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1043-9. doi: 10.1016/j.numecd.2014.04.007. Epub 2014 May 2.
PubMed 24929795
Honda K, Littman DR. The microbiota in adaptive immune homeostasis and disease. Nature. 2016 Jul 7;535(7610):75-84. doi: 10.1038/nature18848.
PubMed 27383982
Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
PubMed 23727169
Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.
PubMed 24890442
Lin CJ, Wu V, Wu PC, Wu CJ. Meta-Analysis of the Associations of p-Cresyl Sulfate (PCS) and Indoxyl Sulfate (IS) with Cardiovascular Events and All-Cause Mortality in Patients with Chronic Renal Failure. PLoS One. 2015 Jul 14;10(7):e0132589. doi: 10.1371/journal.pone.0132589. eCollection 2015.
PubMed 26173073
Marotz CA, Zarrinpar A. Treating Obesity and Metabolic Syndrome with Fecal Microbiota Transplantation. Yale J Biol Med. 2016 Sep 30;89(3):383-388. eCollection 2016 Sep.
PubMed 27698622
Nallu A, Sharma S, Ramezani A, Muralidharan J, Raj D. Gut microbiome in chronic kidney disease: challenges and opportunities. Transl Res. 2017 Jan;179:24-37. doi: 10.1016/j.trsl.2016.04.007. Epub 2016 Apr 30.
PubMed 27187743
Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.
PubMed 26590448
Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.
PubMed 19558344
Rossi M, Johnson DW, Morrison M, Pascoe E, Coombes JS, Forbes JM, McWhinney BC, Ungerer JP, Dimeski G, Campbell KL. SYNbiotics Easing Renal failure by improving Gut microbiologY (SYNERGY): a protocol of placebo-controlled randomised cross-over trial. BMC Nephrol. 2014 Jul 4;15:106. doi: 10.1186/1471-2369-15-106.
PubMed 24996842
Sabatino A, Regolisti G, Brusasco I, Cabassi A, Morabito S, Fiaccadori E. Alterations of intestinal barrier and microbiota in chronic kidney disease. Nephrol Dial Transplant. 2015 Jun;30(6):924-33. doi: 10.1093/ndt/gfu287. Epub 2014 Sep 4.
PubMed 25190600
Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
PubMed 22992469

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease
ClinicalTrials.gov ID: NCT04361097
Acronym / sponsor ID: IF18-00003
Conditions: Chronic Kidney Disease Due to Hypertension, Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
Keywords: chronic kidney disease, fecal microbiota
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
Study start: 7 Aug 2018 (actual)
Primary completion: 7 Nov 2019 (actual)
Study completion: 21 Apr 2020 (actual)
First posted: 24 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

What the investigators want to achieve with the protocol is to identify the impact of intestinal microbiota transplantation on the progression of chronic kidney disease.

Detailed description

What the investigators want to achieve with the protocol is to identify that impact has transplantation intestinal microbiota on the progression of chronic kidney disease

A.-Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD.

C.-Methodological design: Experimental, prospective, double-blind.

D.-Type of study: Controlled clinical trial

E.- Population in study:

-Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60 mL/minute secondary hypertension and/or diabetes, older than 18 years.
- Exclusion Criteria: Malignancies whose last treatment has been less than 5 years, he is receiving antibiotics for any reason during the month prior to enrollment, having received probiotics in the last 3 months, it has been diagnosed with Clostridium difficile infection in the last year, it has been previously subjected to TMF , exacerbations of submitting ERC during the 3 months prior or present at the time of enrollment.
-Criteria for elimination: Failure to comply in the structured patient monitoring, nondelivery of stool samples at set times, the patient decides to no longer participate in the study.

measurements characteristic factors of the progression of kidney disease day 0,10, 30, 60, 90, 120 and 180 be made consisting of:

Proteins in urine 24 hours
Creatinine clearance 24 hours
CBC
serum creatinine
Urea Nitrogen
Urea
Glucose
Uric acid
IS
venous gases

adverse effects questionnaires on days 1, 5, 30 and 60 is performed and quality of life assessment on days 0, 10, 30, 90 and 180.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Prospective, double blind, experimental

Arm	Type	Receives
Faecal microbiota transplant	Experimental	Biological: Faecal microbiota transplantThis group will receive frozen capsules to be ingested orally constituted of TMF with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
Placebo	Placebo comparator	Biological: PlaceboThis group will receive frozen capsules to be ingested orally placebo with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Be diagnosed with CKD and creatinine clearance less than 60 ml / minute secondary to hypertension and / or diabetes.
Age over 18 years

Key exclusion criteria (6 listed)

Malignant neoplasms whose last treatment was less than 5 years
Having received antibiotics for any reason during the month prior to enrollment
Have received probiotics in the last 3 months
Have been diagnosed with Clostridium difficile infection in the last year
Have been previously submitted to TMF

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Faecal microbiota transplantBoth groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.	Biological	Faecal microbiota transplant
PlaceboBoth groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.	Biological	Placebo

Primary outcome

Creatinine Clearance
Time frame: 6 months
Arrest CKD progression

21 secondary outcomes

24-hour Urine Protein
Time frame: 6 months
Serum Creatinine
Time frame: 6 months
Hemoglobin
Time frame: 6 months
Hematocrit
Time frame: 6 months
Leukocytes
Time frame: 6 months
Neutrophils
Time frame: 6 months
Platelets
Time frame: 6 months
Glucose
Time frame: 6 months
Urea Nitrogen
Time frame: 6 months
Uric Acid
Time frame: 6 months
Albumin
Time frame: 6 months
Reactive Protein C
Time frame: 6 months
Chlorine
Time frame: 6 months
Sodium
Time frame: 6 months
Potassium
Time frame: 6 months
Phosphorous
Time frame: 6 months
pH Venous Gasometry
Time frame: 6 months
CO2 pressure venous
Time frame: 6 months
Venous Bicarbonate
Time frame: 6 months
Base Excess
Time frame: 6 months
Lactate
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Background: PubMed 26956193Choi HH, Cho YS. Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives. Clin Endosc. 2016 May;49(3):257-65. doi: 10.5946/ce.2015.117. Epub 2016 Mar 9.
Background: PubMed 25066654Cruz-Mora J, Martinez-Hernandez NE, Martin del Campo-Lopez F, Viramontes-Horner D, Vizmanos-Lamotte B, Munoz-Valle JF, Garcia-Garcia G, Parra-Rojas I, Castro-Alarcon N. Effects of a symbiotic on gut microbiota in Mexican patients with end-stage renal disease. J Ren Nutr. 2014 Sep;24(5):330-5. doi: 10.1053/j.jrn.2014.05.006. Epub 2014 Jul 22.
Background: PubMed 27757226Felizardo RJ, Castoldi A, Andrade-Oliveira V, Camara NO. The microbiota and chronic kidney diseases: a double-edged sword. Clin Transl Immunology. 2016 Jun 10;5(6):e86. doi: 10.1038/cti.2016.36. eCollection 2016 Jun.
Background: PubMed 24929795Guida B, Germano R, Trio R, Russo D, Memoli B, Grumetto L, Barbato F, Cataldi M. Effect of short-term synbiotic treatment on plasma p-cresol levels in patients with chronic renal failure: a randomized clinical trial. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1043-9. doi: 10.1016/j.numecd.2014.04.007. Epub 2014 May 2.
Background: PubMed 27383982Honda K, Littman DR. The microbiota in adaptive immune homeostasis and disease. Nature. 2016 Jul 7;535(7610):75-84. doi: 10.1038/nature18848.
Background: PubMed 23727169Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
Background: PubMed 24890442Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.
Background: PubMed 26173073Lin CJ, Wu V, Wu PC, Wu CJ. Meta-Analysis of the Associations of p-Cresyl Sulfate (PCS) and Indoxyl Sulfate (IS) with Cardiovascular Events and All-Cause Mortality in Patients with Chronic Renal Failure. PLoS One. 2015 Jul 14;10(7):e0132589. doi: 10.1371/journal.pone.0132589. eCollection 2015.
Background: PubMed 27698622Marotz CA, Zarrinpar A. Treating Obesity and Metabolic Syndrome with Fecal Microbiota Transplantation. Yale J Biol Med. 2016 Sep 30;89(3):383-388. eCollection 2016 Sep.
Background: PubMed 27187743Nallu A, Sharma S, Ramezani A, Muralidharan J, Raj D. Gut microbiome in chronic kidney disease: challenges and opportunities. Transl Res. 2017 Jan;179:24-37. doi: 10.1016/j.trsl.2016.04.007. Epub 2016 Apr 30.
Background: PubMed 26590448Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.
Background: PubMed 19558344Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adrian Camacho-Ortiz, PhD principal investigator

Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Creatinine Clearance (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361097, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.