NCT03356990Completed
Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
The investigators want to learn more about how to help people who have chronic kidney disease (CKD). This study will increase the investigators understanding of how diet affects factors that can slow the progression of kidney disease. The investigators are asking 30 adults and 30 children with stage 3 CKD to be part of this study. Participants will supplement their diet with resistant starch for two weeks. The investigators anticipate that the resistant starch will change the bacteria in the intestines to a more beneficial type of bacteria. The investigators will measure a product of these beneficial bacteria called butyrate. The investigators will also determine changes in the gut bacteria and products of the bacteria in the blood.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 14 Nov 2017
- Start date
- 12 Feb 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Arkansas
- Diseases
- Chronic kidney disease
- NCT number
- NCT03356990
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 12 Feb 2018 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of renal transplant
- Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
- Inflammatory bowel disease
- Irritable bowel syndrome
- Colorectal cancer
- History of renal transplant
- Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
- Inflammatory bowel disease
Lab values
- eGFR Cr \> 59 ml/min or \< 30 ml/min
- eGFR \> 59 ml/min and \< 30 ml/min
Age
- Age older than 85 years
- Age younger than 5 years
Other
- Adult
- Use of antibiotics within 1 month
- Use of laxatives within 1 month
- Surgically removed bowel or presence of an ostomy
- Pregnancy
- Inability to obtain written informed consent
- Constipation
- Diarrhea
- Children
- Use of antibiotics within 1 month
- Use of laxatives within 1 month
- Surgically removed bowel or presence of an ostomy
- Pregnancy
- Constipation
- Diarrhea
Who the study is looking for
- Adult
- Between the ages of 18 and 85 years old
- Glomerular filtration rate estimated by creatinine clearance (eGFR Cr):between 59 and 30 ml/min for stage 3 CKD patients
- Urine protein \< 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio \<1 gram/gram or urine microalbumin to creatinine concentration less than 1000 mg/g.
- Children
- Between the ages of 5 and 17 years
- eGFR Cr between 30 and 59 (stage 3 CKD) using the revised Schwartz equation.
- Urine protein \< 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio \<1 gram/gram.
Age in the registry: 5 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.