Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002892187265 Date of Approval: 17/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Fibre (Oats) on the Gut Microbiome of Chronic Kidney Disease Patients and Impact on Kidney Function.
Official scientific title The Effect of β-glucan Prebiotic Fibre (Oats) on the Gut Microbiome of Chronic Kidney Disease Patients (Stage IV and V) and Impact on Kidney Function.
Brief summary describing the background and objectives of the trial Chronic kidney disease (CKD) is a non-communicable disease with an increasing global and local prevalence. End stage kidney disease (ESKD) has many metabolic and nutritional complications requiring intensive medical interventions, which are expensive and compromise patients’ quality of life. Dietary modifications are important in the management of CKD and if instituted early can delay the progression to ESKD. However, adherence to dietary guidelines is low due to the restrictive nature of the renal diet. The traditional diet for CKD prescribes low intakes of fruits, vegetables and wholegrains; this diet minimises potassium and phosphorous consumption thereby limiting fibre intake. The resultant low fibre intake and other disease factors affects the gut microbiome and contributes to gut dysbiosis, inflammation and subsequent CKD progression. . This study aims to investigate the effect of a ß-Glucan prebiotic fibre supplement (oats) on the gut microbiome, uremic toxins and kidney function and other biochemical parameters in CKD stage 4 and 5 patients attending the Tygerberg Hospital outpatient CKD clinic. Inclusion criteria include pre-dialysis patients older than 18 years that are able to give consent and have GFR less than 30 mL/min. Exclusion criteria include patients on antibiotics, prebiotics and probiotics for the last 4 weeks, patients with major gastrointestinal impairments, pregnancy, diabetics and patients who are expected to start dialysis within two months. The objectives of the study are to describe the baseline characteristics of CKD stage 3-5 patients and to measure the effect of the ß-Glucan prebiotic fibre supplement (oats) on the following: the gut microbiome, uremic toxin levels, kidney function and other biochemical parameters . The sample size was calculated using the 2-sample t-test with a 90 % power the calculation using the gut microbiome outcomes. The minimum sample was calculated at 23, due to expected compliance issues 35 will be recruited.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/07/2018
Actual trial start date 08/08/2018
Anticipated date of last follow up 06/09/2019
Actual Last follow-up date 06/03/2020
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group B glucan prebiotic fibre 15g of prebiotic fibre will be given in addition to a renal diet 14 weeks After 4 weeks of following a renal diet, patients will be randomly assigned to either the control group of remaining on the diet or taking the prebiotic fibre in addition to the diet 35
Control Group Diet only All patients will be advised on a renal diet with 0.8g per kg of protein allowance at the baseline visit and then will follow this for 4 weeks before randomization, patients in the control group will remain on this diet 14 weeks All patients will be advised on a renal diet with 0.8g per kg of protein allowance at the baseline visit and then will follow this for 4 weeks before randomization, patients in the control group will remain on this diet 35 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with CKD stage 4 (GFR 15-29 ml/min) and 5 (GFR<15 ml/min) pre-dialysis patients attending the Tygerberg Renal Outpatient Clinic. Patients have to be 18 years or older and able to give informed written consent. Patients on antibiotics, prebiotics or probiotic supplements currently or in the past 4 weeks. Patients with inflammatory bowel disease, bowel malignancy, previous colorectal surgery (or any other serious bowel disorder) Pregnancy, diabetes mellitus, coeliac disease, human immunodeficiency virus (HIV) disease, malignant hypertension, crescentic glomerular nephritis Patients on immunosuppressant medications. CKD patients who are expected to start dialysis within the next 2 months will be excluded. The conditions mentioned above are excluded due to it influencing either the gut microbiome or renal outcomes. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/05/2018 Stellenbosch Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Medical School Francie van Zijl Drive, Parow Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/05/2019 Stellenbosch Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Medical School Francie van Zijl Drive, Parow Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Study the effect of the prebiotic on the following outcomes, sociodemographic outcomes, anthropometric outcomes, kidney and other biochemical outcomes, gut microbiome composition outcomes, uremic toxin composition outcomes, dietary adherence outcomes Baseline, 4, 12 and 18 weeks
Secondary Outcome To describe the meal patterns, cooking patterns and barriers to healthy eating Baseline, 4, 12 and 18 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Renal Clinic Cape Town Francie van Zijl Drive Parow 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Thuthuka Meiring Naude Road, Brummeria Pretoria South Africa
Institutional funds Fancie Van Zijl Drive, Parow Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No sponsors Not applicable Not applicable South Africa no sponsor
COLLABORATORS
Name Street address City Postal code Country
Professor Griet Gloriuex Corneel Heymanslaan 10 Ghent 9000 Belgium
Professor Jaroen Raes Rega Institute Herestraat Leuven 3000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zarina Ebrahim zarina@sun.ac.za +27219389137 Francie van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Lecturer and PhD student
Role Name Email Phone Street address
Public Enquiries Zarina Ebrahim zarina@sun.ac.za +27219389137 Francie van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Lecturer and PhD student
Role Name Email Phone Street address
Scientific Enquiries Zarina Ebrahim zarina@sun.ac.za +27219389137 Francie van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Lecturer and PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes it will be available for sharing but only if investigators apply though an approved independent scientific committee, results from the articles only will be available for sharing after deindentification of participants. Statistical Analysis Plan,Study Protocol after 9 months of publication and after 24 months of being published Investigators apply though an approved independent scientific committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available Yes Results will be reported as per outcome statistical summary in the document below 08/09/2020 24/03/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks The protocol has not been published
Changes to trial information