ConstipationNCT06738550
Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.
A study testing inulin and Lactulose oral solution in people with Constipation and Peritoneal Dialysis (PD), run by NIN Institute at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Peritoneal Dialysis (PD), CKD
- What is being tested?
- inulin and Lactulose oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Hospitalizations within the last month for peritonitis
- Pregnant women
- Patients with psychiatric illnesses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients
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.
Read the detailed description
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).
- Conditions
- Constipation, Peritoneal Dialysis (PD), CKD, Quality of Life (QOL)
- Being tested
- inulin, Lactulose oral solution
- Keywords
- CKD, Peritoneal Dialysis (PD), Constipation, Quality of life (QOL), Gastrointestinal symtoms
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
Also called Inulin prebiotic
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 solutionDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lactulose oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline intervention and 6 months
Secondary outcomes (1)
Dietary intake (kcal/kg/day)
Changes in dietary caloric intake of patients at baseline and month 6
Measured: baseline intervention and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Mar 2023
- Primary completion30 Jul 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NIN Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ari Cisneros-Hernández, Centro Medico Issemym
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738550
- Sponsor's protocol ID
- NI0002/24
- Status last verified
- Dec 2024
- First submitted
- 23 Sep 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT06738550
- Acronym / sponsor ID
- NI0002/24
- Conditions
- Constipation, Peritoneal Dialysis (PD), CKD, Quality of Life (QOL)
- Keywords
- CKD, Peritoneal Dialysis (PD), Constipation, Quality of life (QOL), Gastrointestinal symtoms
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- NIN InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Inulina | Experimental | Dietary Supplement: inulinIn 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 |
| Lactulosa | Placebo comparator | Drug: Lactulose oral solutionIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years
- Beginning of peritoneal dialysis in the last month
- Constipation
- Medical follow-up by nephrology every month
- Without Irritable Bowel Syndrome
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inulinAlso: Inulin prebioticIn 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 | Inulina |
| Lactulose oral solutionIn 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 | Drug | Lactulosa |
Primary outcome
Constipation
Time frame: 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
Time frame: 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
1 secondary outcome
Dietary intake (kcal/kg/day)
Time frame: baseline intervention and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin and Lactulose oral solution in people with Constipation and Peritoneal Dialysis (PD), run by NIN Institute at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation (time frame: Baseline intervetion and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.