Effect of Oral Consumption of a Symbiotic Gelatin on the Presence of Gastrointestinal Symptoms and Quality of Life in People With Chronic Kidney Disease

NCT06745245 | Active Not Recruiting

• 1 other identifier: NI0003/24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with chronic kidney disease (CKD) there is a high prevalence of gastrointestinal disorders and negative changes in the microbiota and assimilation of nutrients, which is associated with an increased risk of morbidity and mortality.

Conditions

Chronic Kidney Disease(CKD); Dysbiosis Symptoms Linked to Pathology; Probiotics Supplement

Keywords

chronic kidney disease; probiotics

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal symptoms

  Evaluate the presence and intesity of gastrointestinal symptoms for all patients from baseline to 1.5 month of intervention, through a Likert escale, with 5 being very intense and 1 being almost null.

  baseline intervention and 1.5 months

• Renal function

  Evaluate Glomerular Filtration Rate using the CKD-EPI creatinine equation in all patients at baseline and one and a half months

  Baseline intervention and one and a half months

Secondary Outcomes (2)

• Adherence to oral supplement

  At 1.5 months of intervention

• Adverse effects

  At baseline and 1.5 months of intervention

Study Arms (1)

Experimental: Arm Intervention

EXPERIMENTAL

Intervention group: The specialized oral supplement is provided, with the consumption of 1 dose (15 g) per day along with individualized nutritional advice. For 1.5 months

Dietary Supplement: Nutritional counseling and supplementation with a gelatin with prebiotic fiber and probiotic microorganisms

Interventions

Nutritional counseling and supplementation with a gelatin with prebiotic fiber and probiotic microorganisms DIETARY_SUPPLEMENT

One serving (15 g) of symbiotic gelatin

Also known as: Symbiotic gelatin

Experimental: Arm Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous hospitalizations in the last month.
• Diagnosis of comorbidities such as cancer, decompensated heart failure, decompensated lung disease, decompensated liver disease, HIV, infection present within the last 3 months (chronic and/or acute) stroke, malabsorption syndrome or allergy to any ingredient of the nutritional supplement.
• Colon surgeries in the past 6 months (obstruction, resection of a portion).
• Presence of ostomies.
• Who show current treatment of antibiotics or oral iron.

You may not qualify if:

• Failure to attend evaluation and biochemical tests at the beginning and end of the study.
• Non-compliance with ≥ 10% of probiotics + fiber intakes (≥ 3 sachets in 15 days) during the intervention period.
• Identification of serious adverse effects.
• Withdrawal of voluntary participation by the patient.

Sponsors & Collaborators

• NIN Institute: lead
• Centro Medico Issemym: collaborator

Study Sites (1)

Centro Médico Issemym

Toluca, 50080, Mexico

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Nutrition Assessment; Dietary Supplements

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paola Azucena Alvarado Pelayo, Bachelor

  NIN Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: In the intervention, the specialized oral supplement plus very general nutritional advice is provided, to the participants in the different stages of kidney disease, as well as in the presence of replacement therapy, laboratory studies (blood and urine) are indicated to all groups.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: December 20, 2024
• Study Start: September 12, 2024
• Primary Completion: September 12, 2025
• Study Completion: December 20, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)