Effect of Oral Consumption of a Symbiotic Gelatin on the Presence of Gastrointestinal Symptoms and Quality of Life in People With Chronic Kidney Disease
Chronic Kidney Disease(CKD)Dysbiosis Symptoms Linked to PathologyProbiotics Supplement
Investigational drug(s) / intervention(s)
Nutritional counseling and supplementation with a gelatin with prebiotic fiber and probiotic microorganisms
Nutritional counseling and supplementation with a gelatin with prebiotic fiber and probiotic microorganisms: One serving (15 g) of symbiotic gelatin
Study summary
In patients with chronic kidney disease (CKD) there is a high prevalence of gastrointestinal disorders and negative changes in the microbiota and assimilation of nutrients, which is associated with an increased risk of morbidity and mortality.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Previous hospitalizations in the last month.
* Diagnosis of comorbidities such as cancer, decompensated heart failure, decompensated lung disease, decompensated liver disease, HIV, infection present within the last 3 months (chronic and/or acute) stroke, malabsorption syndrome or allergy to any ingredient of the nutritional supplement.
* Colon surgeries in the past 6 months (obstruction, resection of a portion).
* Presence of ostomies.
* Who show current treatment of antibiotics or oral iron.
Exclusion Criteria:
* Failure to attend evaluation and biochemical tests at the beginning and end of the study.
* Non-compliance with ≥ 10% of probiotics + fiber intakes (≥ 3 sachets in 15 days) during the intervention period.
* Identification of serious adverse effects.
* Withdrawal of voluntary participation by the patient.
Primary outcome measure(s)
Gastrointestinal symptoms — baseline intervention and 1.5 months Evaluate the presence and intesity of gastrointestinal symptoms for all patients from baseline to 1.5 month of intervention, through a Likert escale, with 5 being very intense and 1 being almost null.
Renal function — Baseline intervention and one and a half months Evaluate Glomerular Filtration Rate using the CKD-EPI creatinine equation in all patients at baseline and one and a half months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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