inulin: In the patients of the experimental group, the nutritional intervention is personalized, agave inulin supplementation is provided 9 gr per day, A 6-month follow-up is provided
Lactulose oral solution: In the patients of the experimental group, the nutritional intervention is personalized, A 6-month follow-up is provided and taken syrup lactulose 10 ml every 8 hours
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Over 18 years
* Beginning of peritoneal dialysis in the last month
* Constipation
* Medical follow-up by nephrology every month
* Without Irritable Bowel Syndrome
* No frailty criteria
Exclusion Criteria:
* Patients who don\'t to take the supplement
* Patients with diarrhea
* Patients with a diagnosed intestinal disorder
* Allergic to any ingredient of the supplement.
* Previous probiotic and/or prebiotic supplementation in the last month
* Diagnosis of comorbidities such as cancer, decompensated heart failure, decompensated pulmonary disease, decompensated liver disease, HIV, infection present within the last 3 months (chronic and/or acute), stroke and malabsorption syndrome.
* Hospitalizations within the last month for peritonitis
* Pregnant women
* Patients with psychiatric illnesses
Primary outcome measure(s)
Constipation — Baseline intervetion and 6 months Change stool consistency as assessed by the Bristol scale
1 and 2 is Cosntipacion 3 and 4 is Normal 5, 6 and 7 is diarrhea
Gastrointestinal symptoms — Baseline intervention and 6 months Changing the intensity of gastrointestinal symptoms caused by CKD and constipation as assessed with the PAC-SYM QUESTIONNAIRE
Designed to assess the patient's experience of constipation over two weeks by measuring symptoms and symptom severity. It is a self-reported questionnaire consisting of 12 symptoms divided into three domains: abdominal, rectal and stool, with responses rated on a 5-point Likert scale.
Scoring The PAC-SYM is a tool that can be used to understand the severity of your patient's constipation and help you identify key symptom areas. A total PAC-SYM score ranges from 0 to 48 with a low score indicating fewer symptoms and of lower severity.
Absence of symptom = 0 Mild = 1 Moderate = 2 Severe = 3 Very severe = 4
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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