Constipation affects a large part of the population with Chronic Kidney Disease (CKD),
and in Peritoneal Dialysis (PD) it is the most common symptom derived from multiple
factors, including dietary restrictions causing insufficient fiber intake, water
restriction, drug consumption and the change in the intestinal microbiota derived from
uremic toxins during this stage, leading to a poor quality of life in the patient and
consequently an alteration in the patient's nutritional status. In turn, constipation
has become a risk factor in the development of cardiovascular diseases, of which patients
with CKD have a higher incidence. This research aims to determine the effects of agave
inulin supplementation on constipation and quality of life in peritoneal dialysis
patients in order to establish a strategy to support patient treatment and improve uremic
syndrome.
Lactulose syrup is usually used to prevent and treat constipation in doses from 10 ml
every 8 hours.
The present research aims to determine the effects that agave inulin supplementation may
have on constipation and quality of life in peritoneal dialysis patients, and to
establish a strategy to support the patient's treatment and improve uremic syndrome.
Stage 1 Patients will be selected by the peritoneal dialysis team to identify the
patients who start RRT, once identified, they will be referred to the nutrition office,
where an initial evaluation of the patient will be made and if they meet the inclusion
criteria, the informed consent will be explained and if they accept, they will be
randomly assigned to the group they are assigned to. The laboratories requested to the
patients are the same as those routinely requested by the treating physician. The
characteristics of the nutritional intervention are detailed below. The characteristics
of the first visit are detailed below.
Visit 1:
Evaluation of selection/inclusion criteria
Assessment in medical consultation
Signing of consent form.
Initial evaluation (File with: clinical, anthropometric, biochemical, dietary data).
Constipation evaluation with Bristol scale
Evaluation of quality of life with KDQOL-SF questionnaire.
Delivery of food plan and nutritional recommendations
Indication and delivery of the supplement according to the group.
Indicate that unfinished product should be returned.
Request for laboratory tests (routine tests that the nephrologist requests
consultation after consultation).
Appointment every 30 days for delivery of supplement and adherence evaluation.
Stage 2 In the second stage, patients are followed month by month for medical and
nutritional evaluation, evaluating anthropometry, biochemistry, clinical signs,
patient's diet, therapeutic adherence to supplementation, evaluation of
gastrointestinal symptoms and constipation, and evaluation of quality of life. The
corresponding data are recorded in a database. The characteristics of the visit are
detailed below.
Visit 2, 3, 4 and 5:
Intermediate medical evaluation
Intermediate evaluation (File with: clinical, anthropometric, biochemical, dietary
data, adherence evaluation).
Constipation evaluation with Bristol scale and roma criteria.
Supplement delivery
Request for laboratory tests (routine tests requested by the nephrologist
consultation after consultation).
Appointment every 30 days.
Stage 3 In this stage the supplementation is suspended, a medical and nutritional
evaluation is made evaluating anthropometry, biochemistry, clinical signs, patient's
diet, therapeutic adherence to supplementation, evaluation of gastrointestinal symptoms
and constipation and evaluation of quality of life. The corresponding data are recorded
in a database. The characteristics of the visit are detailed below.
Visit 6: discontinue supplementation.
Final evaluation (clinical record with anthropometric, clinical, biochemical and
dietary data, evaluation of therapeutic adherence).
Evaluation of constipation with Bristol scale and roma criteria.
Request for laboratory tests (routine tests that the nephrologist requests
consultation after consultation).
Appointment after 30 days. In this last stage, the patient will be seen again after
one month to evaluate the post-supplementation period.
In this last stage, the patient will be seen again after one month to evaluate the
post-supplementation period.
Visit 7:
Post-intervention period evaluation (file with: clinical, anthropometric,
biochemical, dietary data).
Evaluation of constipation with Bristol scale and roma criteria.
Evaluation of quality of life with KDQOL-SF questionnaire.
Characteristics of the nutritional intervention:
In the nutritional intervention, the patient's family medical history, clinical
indicators such as T/A, signs of nutritional deficiency such as dehydration, muscle and
fat depletion, edema and gastrointestinal symptoms and degree of constipation will be
evaluated by clinical history.
Biochemical indicators are tests that are commonly requested in nephrology follow-up
consultations, will be evaluated.
For the evaluation of anthropometric indicators, body composition will be evaluated by
means of anthropometry (plyometry and circumferences) and a Tanita scale, identifying the
patient's fat and muscle compartment; in the dietary evaluation, the intake of
energy, carbohydrates, lipids and proteins will be evaluated by means of a 24-hour
reminder. With the above, a nutritional diagnosis is made and a dietary plan for the
patient that includes: general recommendations, explanation of portions, explanation of
the food for renal disease and a menu with food options that the patient can follow and
exchange with the list of foods provided.
Ethical considerations. Requesting their signature for consent. Human research guidelines
will be respected according to "good clinical practice". The protocol will be
submitted to the Bioethics Committee of the Centro Medico ISSEMyM, Metepec, Edo. México.
Care will be taken to respect the recommendations of the Helsinki Declaration in its last
correction made during the 64th Annual Assembly organized by the World Medical
Association (2013).
