Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older A… (NCT05923723) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2024.
Colombia56 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range
60 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.