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

NCT06738550 | Enrolling By Invitation DMC

• 1 other identifier: NI0002/24
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Peritoneal Dialysis (PD); CKD; Quality of Life (QOL)

Keywords

CKD; Peritoneal Dialysis (PD); Constipation; Quality of life (QOL); Gastrointestinal symtoms

Outcome Measures

Primary Outcomes (2)

• Constipation

  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

  Baseline intervetion and 6 months

• Gastrointestinal symptoms

  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

  Baseline intervention and 6 months

Secondary Outcomes (1)

• Dietary intake (kcal/kg/day)

  baseline intervention and 6 months

Study Arms (2)

Inulina

EXPERIMENTAL

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

Dietary Supplement: inulin

Lactulosa

PLACEBO COMPARATOR

In the patients of the control group, the nutritional intervention is personalized, A 6-month follow-up is provided and taken syrup lactulose 10 ml every 8 hours

Drug: Lactulose oral solution

Interventions

inulin DIETARY_SUPPLEMENT

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

Also known as: Inulin prebiotic

Inulina

Lactulose oral solution DRUG

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

Lactulosa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NIN Institute: lead

Study Sites (1)

Centro Medico ISSEMyM, Toluca

Metepec, State of Mexico, 52170, Mexico

Location

MeSH Terms

Conditions

Constipation

Interventions

Inulin; Lactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Disaccharides; Oligosaccharides; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: control group with lactulose syrup 10 ml every 8 hours and nutritional intervetion intervention group with agave inulin 9 gr per day and nutritional intervetion

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: December 17, 2024
• Study Start: March 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 31, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)