Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2022-2023.
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ClinicalTrials.gov Identifier: NCT05923723 |
Recruitment Status :
Not yet recruiting
First Posted : June 28, 2023
Last Update Posted : February 6, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation Chronic Idiopathic | Other: FIBNUTRITION Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of a Dietary Intervention Composed of Flaxseed, Chia, and Psyllium for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2022-2023. |
Estimated Study Start Date : | March 15, 2024 |
Estimated Primary Completion Date : | May 15, 2024 |
Estimated Study Completion Date : | May 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Dietary intervention |
Other: FIBNUTRITION
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). |
Placebo Comparator: Placebo |
Other: Placebo
The placebo is a dietary product composed of maltodextrin, cornstarch, orange flavoring, and stevia. |
- Adequate relief at 6 weeks [ Time Frame: 6 week ]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.
- Adequate relief at 3 weeks [ Time Frame: 3 week ]Proportion of older adults with satisfactory relief of general constipation symptoms after 3 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.
- Change from baseline in the score of the Patient Assessment of Constipation Quality of Life (PAC-QOL). [ Time Frame: Baseline, week 6 ]Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). This tool consists of 28 items grouped into 4 subscales corresponding to: Concerns and Worries (11 items), Physical Discomfort (4 items), Psychosocial Discomfort (8 items), and Satisfaction (5 items). A 5-point Likert scale is used as a response scale, ranging from 0 (Not at all / Never) to 4 (Extremely / Always). A difference of 0.8 points in the overall PAC-QOL assessment (Before and after the intervention) is established as the minimally important difference (improvement) to be detected.
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Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923723
Contact: Santiago Gomez | 3008038773 | sagomez@ces.edu.co |
Responsible Party: | Santiago Gomez Velasquez, Research Professor, doctoral student in Epidemiology and Biostatistics., CES University |
ClinicalTrials.gov Identifier: | NCT05923723 |
Other Study ID Numbers: |
Constipation psyllium |
First Posted: | June 28, 2023 Key Record Dates |
Last Update Posted: | February 6, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Constipation Signs and Symptoms, Digestive |