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Effect of fibers on intestinal transit and inflammation of patients with Pre-Dialytic Chronic Renal Disease

Effect of prebiotics on intestinal transit and inflammation profile of patients with Pre-Dialytic Chronic Renal Disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3wrnrf
Enrollment
Unknown
Registered
2019-09-28
Start date
2019-09-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

constipation

Interventions

The study will be conducted over 8 weeks (60 consecutive days), in which 62 participants will be included, 31 in each group). In the first week, individuals will be drawn and divided in placebo group
Behavioural
Dietary supplement

Sponsors

Faculdade de Medicina de Botucatu - Unesp
Lead Sponsor
Faculdade de Medicina de Botucatu - Unesp
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with non-dialytic stage V chronic kidney disease; over 18 years of age; who do not have gastroenterological pathologies; do not have cancer; and do not use continuous laxatives

Exclusion criteria

Exclusion criteria: Patients younger than 18 years of age; with gastroenterological pathologies; pregnant women of any gestational age; cancer; patients on continuous use of laxatives; patients with CKD of any other stage

Design outcomes

Primary

MeasureTime frame
Outcome 1 - Improvement of intestinal habit after supplementation with prebiotics during a period of 60 days; assessed using the criteria of Rome III and the Bristol scale. These parameters are used for the diagnosis of intestinal constipation and in the case of the Bristol scale, it is used to describe the characteristics of the stool, which may help to identify the improvement of the intestinal habit. That is, presence or absence of constipation by means of the criteria of Rome III and score from 1 to 7 by the bristol scale (the categories closest to number 1, characteristic of constipation and when closer to the number 7 characteristic of diarrhea).

Secondary

MeasureTime frame
Outcome 2 - Improvement of the lipid profile after 60 consecutive days of prebiotic supplementation; through the evaluation and dosage of total cholesterol and fractions and triglycerides and also by comparing the dosage of medication; ie, reduction of serum levels of total cholesterol and triglycerides without changes in the dosages of medications. ;Outcome 3 -Reduction of inflammation; by reducing serum levels of C-reactive protein; when compared to previous evaluations from study inclusion).

Countries

Brazil

Contacts

Public ContactMarina Berbel Bufarah

Faculdade de Medicina de Botucatu - Unesp

mnberbel@fmb.unesp.br+55-14-997402119

Outcome results

None listed

Source: REBEC (via WHO ICTRP)