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New treatment option for Oral Uremic Toxin Absorbent
Official title Study of Oral Uremic Toxin Absorbent/Probiotics to Modulate Systemic Inflammation and Retard the Progression of Chronic Kidney Disease in Patients With Diabetes.
ClinicalTrials.gov ID: NCT07333313
What this study is testing
- What it's testing
- Diabetes mellitus (DM) is a chronic inflammatory disease characterized by insufficient insulin secretion or insulin resistance, leading to hyperglycemia. Chronic inflammation and immune system dysfunction are characteristic of DM and can produce a plethora of cytokines and chemokines, thereby contributing to diabetic complications such as cardiovascular events and diabetic vasculopathy in DM.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Age \> 20 years old but not pregnant on the day of screening.
- DKD patients with stable renal function (Cre elevation \< 0.3 mg/dL for at least 30 days) and PCS level (fluctuation \< 10% for at least 30 days)
- Group 1: 120 DKD patients with 45\<eGFR\<60 ml/min/1.73m2 in stable status. Group 2: 120 DKD patients with 30\<eGFR\<45 ml/min/1.73m2 in stable...
You likely can't join if
- Baseline eGFR \> 90 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL.
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL.
- Active peptic ulcer, esophageal varices, ileus or under fasting status
- Previous gastrointestinal operation.
- Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools.
See the full eligibility criteria
- Age \> 20 years old but not pregnant on the day of screening.
- DKD patients with stable renal function (Cre elevation \< 0.3 mg/dL for at least 30 days) and PCS level (fluctuation \< 10% for at least 30 days)
- Group 1: 120 DKD patients with 45\<eGFR\<60 ml/min/1.73m2 in stable status. Group 2: 120 DKD patients with 30\<eGFR\<45 ml/min/1.73m2 in stable status. Group 3: 60 DKD patients with 15\<eGFR\<30 ml/min/1.73m2 in stable...
- Baseline eGFR \> 90 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL.
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL.
- Active peptic ulcer, esophageal varices, ileus or under fasting status
- Previous gastrointestinal operation.
- Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools.
- Incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
- Solid organ or hematological transplantation recipients.
- Evidence of obstructive kidney injury or polycystic kidney disease.
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
- Patients with Immune Deficiency Syndrome.
- Antibiotics or probiotics treatment within the last 3 months before enrollment and during follow-up period.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.