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Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This is a randomized controlled clinical study realized in the nephrology service of the Centro Medico ISSEMyM hospital in Metepec, State of Mexico, including new patients on Peritoneal Dialysis (PD) over 18 years of age with constipation criteria, the Bristol scale and Rome IV Criteria were used, with a 6-month follow-up with a personalized diet plan, intervention group supplementation with agave Tequiliana blue variety inulin with an initial dose of 9 grams per day, the control gruop recived lactulosa. Data were obtained from the clinical history comorbidities present in the patients, anthropometric data such as weight, % of fat, % of body water, Fat Free Mass (FFM) obtained using a TANITA scale model BC-533; skin folds were obtained using a slim Guide plicometer, dietary data such as energy intake (kcal), protein intake, fluid intake, were estimated using a 24 hr reminder. A questionnaire was also applied to measure gastrointestinal symptoms and their evolution with the intervention, in addition to the KDQOL-SF to evaluate the quality of life of the patients.
Trial Details
NCT Number NCT06738550
Lead Sponsor NIN Institute
Conditions
(from sponsor)
Constipation, Peritoneal Dialysis (PD), CKD, Quality of Life (QOL)
Related terms Constipation
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov