Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2024.

NCT05923723 | Completed

• 1 other identifier: Constipation psyllium
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this clinical trial is to determine if a dietary intervention for the treatment of chronic idiopathic constipation in older adults in the city of Medellin is effective (works well), focusing on the population in geriatric care centers and institutions. The goal is to obtain scientific evidence that allows determining the efficacy of this intervention for the non-pharmacological treatment of constipation in the elderly. The main question to be answered is: "Is a dietary product designed with psyllium, chia, and flaxseed a reliable and effective treatment for managing constipation in older adults?" The intervention and follow-up period for the study has been set at 6 weeks (45 days). During this time, participants will receive orally, once a day (every 24 hours), 1 tablespoon (20g) of the product - FIBNUTRITION - (a natural food product rich in fiber, with its main components being flaxseed, chia, and psyllium), mixed in an 8oz glass (approximately 250ml) of room temperature water using a blender (following the manufacturer's instructions for use). The product will be provided to each patient in the morning before breakfast. The proposed research corresponds to an intervention study, specifically a randomized, controlled, double-blind, multicenter clinical trial. The researchers will compare an intervention group (dietary intervention) with a control group (placebo: a similar product that does not contain fiber or components that can alter the intestinal tract) to observe if there is a difference of at least 40% in the prevalence of satisfactory relief of constipation symptoms (desired primary effect criterion) between the two groups.

Conditions

Constipation Chronic Idiopathic

Outcome Measures

Primary Outcomes (1)

• Adequate relief at 6 weeks

  Proportion of older adults with satisfactory relief of general constipation symptoms after 6 weeks of intervention initiation. A binary assessment measure of "satisfactory relief" (Yes/No) corresponding to the question: "In comparison to your health before starting the treatment, do you feel that the general symptoms of constipation have improved satisfactorily during the past seven days?" is used.

  6 week

Secondary Outcomes (2)

• Adequate relief at 3 weeks

  3 week

• Change from baseline in the score of the Patient Assessment of Constipation Quality of Life (PAC-QOL).

  Baseline, week 6

Study Arms (2)

Dietary intervention

EXPERIMENTAL

Other: FIBNUTRITION

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

FIBNUTRITION OTHER

The dietary product selected for the study is commercially known as FIBNUTRITION, marketed in Colombia by Bio-Nutrition S.A.S with sanitary registration number NSA-001942-2016. Ingredients of the product: Flaxseed, Chia seeds, Psyllium, Polydextrose, Oat flour, Apple, Orange, Artificial flavor (Orange), Pineapple, Nopal, Xanthan gum (thickener), Silicon dioxide, Stevia (Natural sweetener), Lactobacillus Acidophilus Bifidus Casei (Prebiotics), Sodium Benzoate (Preservative), and Turmeric (Natural colorant).

Dietary intervention

Placebo OTHER

The placebo is a dietary product composed of maltodextrin, cornstarch, orange flavoring, and stevia.

Placebo

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 or older who meet the Rome IV criteria for functional constipation and reside in a long-term care facility in the city of Medellin (Annex 1).
• Older adults who score between 0 and 2 errors on the Pfeiffer Questionnaire (SPMSQ) to detect cognitive impairment in older adults (81). Older adults with cognitive impairment may have difficulties identifying symptoms or remembering their occurrence, which is why they will be excluded from the study

You may not qualify if:

• Older adults with known organic intestinal disease, a history of abdominal or pelvic radiation, previous intestinal surgery or severe liver or kidney disease, any previous abdominal or pelvic cancer, prostate problems, abdominal hernia, known intestinal cancer, and recent abdominal surgery. Other comorbidities that could interfere with the implementation or interpretation of the study.
• Older adults who have used pharmacological and non-pharmacological agents including laxatives in the two weeks prior to the start of the study will be excluded from the study.

Sponsors & Collaborators

• CES University: lead

Study Sites (2)

FUNDACOL

Medellín, Antioquia, 05000, Colombia

Location

Prososerh

Medellín, Antioquia, 05000, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor, doctoral student in Epidemiology and Biostatistics.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 28, 2023
• Study Start: March 15, 2024
• Primary Completion: June 18, 2024
• Study Completion: June 25, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)