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New treatment option for Chronic Kidney Disease 5D
Official title Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05071131
What this study is testing
- What it's testing
- An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men and women in a ratio of 1:1
- Age 18-75 years
- Body mass index 25.0 - 39.9 kg/m\^2
- End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months
You likely can't join if
- Malignant diseases
- Recent or current hospitalization
- Postoperative phase
- Acute infections
- Malnutrition
- Antibiotic treatment within the last 4 weeks
See the full eligibility criteria
- Men and women in a ratio of 1:1
- Age 18-75 years
- Body mass index 25.0 - 39.9 kg/m\^2
- End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months
- Malignant diseases
- Recent or current hospitalization
- Postoperative phase
- Acute infections
- Malnutrition
- Antibiotic treatment within the last 4 weeks
- Regular intake of probiotics and/or prebiotics
- Change of body weight of more than 2 kg in the month prior to study entry
- Known drug or alcohol abuse Changes applied in July 2022 according to amendment no. 1:
- Two inclusion criteria were changed to improve recruitment
- Age range was changed from 18-70 to 18-75 years
- BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m\^2
- The intervention scheme was adapted to increase patient adherence
- A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days Changes applied in January 2024 according to amendment no...
- One inclusion criteria was changed to improve recruitment
- BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
- Last visit was brought foward by 4 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. 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.