Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05923723 |
| Other study ID # |
Constipation psyllium |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2024 |
| Est. completion date |
June 25, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
CES University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Population
Older adults residing in long-term care centers in the city of Medellín who meet the
diagnostic criteria of Rome IV for functional or idiopathic constipation, aged over 60 years.
Sampling Design
The sample size calculation was performed using G Power 3.1.9.7 software (78). The procedure
was conducted considering a 40% difference for the desired primary outcome criterion between
the two groups, assuming prevalences of 10% in the control group and 50% in the intervention
group, based on previous publications with similar designs to identify a minimum clinically
relevant difference (35, 79, 80). With a bilateral α of 0.05 and a statistical power of 0.8,
a sample size of 46 individuals was calculated, with a 20% increase to account for potential
losses or dropouts, resulting in a total of 28 individuals per group, equivalent to a final
sample of 56 participants.
Estimated Start and End Dates
The start of the trial is contingent upon approval from the Doctoral Committee and the
Institutional Ethics Committee of University CES. Once the research proposal is approved, the
study's start date will be determined, projected for the first half of 2024. The maximum
total duration of the clinical period will be two (2) months, after which the data collected
will be analyzed and discussed based on the proposed analyses, followed by the presentation
of results and conclusions.
Recruitment Period
This phase is projected to last a maximum of 8 weeks, with recruitment expected to begin in
february 2024 and extend until june of the same year. The recruitment period will take place
prior to the clinical period. The tentative deadline for accepting new cases is set for Abril
15, 2023. Prior to enrollment in the study, the principal investigator will verify compliance
with inclusion criteria and the absence of exclusion criteria based on a personal interview.
Randomization Process
A block randomization procedure, also known as "permuted blocks," will be carried out to
ensure periodic balance in the number of subjects assigned to each intervention group.
This procedure will be conducted in three steps:
- The size and number of blocks necessary for the study will be determined, where the size
should be a multiple of the number of trial groups.
- All possible permutations within each block will be listed.
- A randomization code will be generated based on the order of selection for each block.
After completing the assignments for each block, it will be verified that the same
number of individuals is allocated to each group.
Intervention and Follow-up Period
The duration of intervention and follow-up for each subject in the study has been set at 6
weeks (45 days). During this time, 1 tablespoon (20g) of the product - FIBNUTRITION - will be
orally administered once a day (every 24 hours) in an 8oz (approximately 250ml) glass of room
temperature water, blended in a blender (following the instructions for use provided by the
manufacturer). The product will be delivered to each patient in the morning before breakfast.
Adverse Events
According to the Ministry of Social Protection of Colombia, in Resolution 2378 of 2008,
adverse events are defined as "any adverse medical occurrence in a patient or subject of a
clinical investigation to whom a pharmaceutical product has been administered, which does not
necessarily have a causal relationship with this treatment. Therefore, an adverse event (AE)
can be any unfavorable and unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal (investigational)
product, whether or not related to it."
Additionally, the Ministry of Social Protection defines a Serious Adverse Event (SAE) as "any
adverse medical occurrence in a patient or subject of a clinical investigation to whom a
pharmaceutical product has been administered, which does not necessarily have a causal
relationship with this treatment. Therefore, an adverse event (AE) can be any unfavorable and
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally
associated with the use of a medicinal (investigational) product, whether or not related to
it, which at any dose:
1. Results in death,
2. Is life-threatening,
3. Requires hospitalization of the patient or prolongation of existing hospitalization,
4. Results in persistent or significant disability/incapacity."
No serious adverse events are expected in this research due to the nature and components of
the product under study. However, the possible occurrence of simple adverse events such as
diarrhea, abdominal distension, or increased constipation is considered.
Recording and Reporting of Adverse Events
All adverse events that may occur during the intervention phase of the trial will be
incorporated into a participant's logbook. The following steps will be followed for each
adverse event:
- Due to the participants being older adults living in long-term care centers, each of
these institutions has nursing staff who are aware of the research and will report any
adverse events that may occur in the participants.
- In the event of an adverse event, the institution where the study is being conducted
assumes responsibility for the care, assistance, and risks associated with the use of
the food product.
- The report will be made to the institution's director, and if necessary, the patient's
healthcare route will be activated through the social security system to which the
patient is affiliated, whether it is a contributory or subsidized regime.
- The research will have the permanent availability of a gastroenterologist, who will have
direct telephone communication with the nurses from each participating institution. In
the event of an adverse event, the gastroenterologist will be responsible for diagnosing
the severity of the event and deciding whether to activate the healthcare route.
- In the occurrence of any of the expected adverse events (diarrhea, abdominal distension,
or increased constipation), the participant will be withdrawn from the study, and the
treatment assignment will be suspended.
- Through the participants' characterization form (pretest), the study will establish a
clear healthcare route for each participant based on their affiliation characteristics
with the healthcare system (regime, healthcare provider for regular consultations,
healthcare provider for emergency care).
Information Collection Techniques
Sources of Information
The study will use primary sources of information through the application of a survey
designed for sociodemographic characterization and the Patient Assessment of Constipation
Quality of Life Questionnaire (PAC-QOL).
Data Collection Techniques
For the identification of the study population, a characterization process will be conducted
in each participating long-term care center to assess the presence of idiopathic constipation
using the Rome IV criteria. Older adults who meet the clinical diagnostic criteria and the
pre-defined inclusion criteria will be the study population from which the sample and
respective experimental groups will be selected. The data collection process for both the
intervention and control groups will be done through the completion of pretest and posttest
forms, which include sociodemographic characteristics and the Patient Assessment of
Constipation Quality of Life Questionnaire (PAC-QOL). The collected information will provide
baseline data for the characterization of both groups to subsequently perform the respective
assessment of results according to the primary and secondary criteria.
A double-blind masking process will be implemented, where neither the participants nor the
investigator will know which group is assigned to the treatment. The measurement of outcomes
will be conducted by the principal investigator, who will apply the respective instrument
while maintaining the assigned group of each participant masked throughout the study. All
participants, both in the control and intervention groups, will be assigned an alphanumeric
code, and comprehensive data collection forms will be applied at each measurement point
(baseline and final), ensuring privacy and autonomy in responses. Support and resolution of
participants' concerns will be provided when necessary, and the complete completion of the
instrument will be verified. After completing the measurements, the data will be entered into
a plain Excel file.
Error and Bias Control
The study's quality control will include methodological strategies for monitoring and
follow-up, aimed at improving the reliability and validity of the intervention and respective
measurements.
- Selection: The strict compliance with inclusion and exclusion criteria will be directly
supervised by the principal investigator. To avoid self-selection bias, the survey (Rome
IV) will be described as a health survey without any mention of gastrointestinal
symptoms or disorders.
- Measurement: The pretest survey will include two attention test questions with
multiple-choice options, specifically asking the older adult to enter a particular
response. Those who do not respond correctly to either of the questions will be excluded
from the survey without completing it. The measurement methods for both clinical
criteria and sociodemographic characterization of the older adult will be standardized,
ensuring no measurement differences between groups. Adherence to the protocol will be
supervised to ensure that the treatment was delivered to each participant as
standardized. This will include protocol training and keeping a record of each delivery.
- Confounding: Variables related to pre-existing morbidities, polypharmacy, and diet will
be specifically controlled. The study will focus on evaluating the group outcome in
terms of satisfactory relief, rather than conducting individual analysis on each older
adult.
- Matching and randomization errors: The treatment delivery will be based on a principle
of simple random distribution (random assignment numbers in Excel) performed by
technical personnel from the NUTRAL group. It is acknowledged that older adults with
cognitive impairment may be present, resulting in difficulties in identifying symptoms
or remembering their occurrence. To control this potential error, only older adults who
record between 0 and 2 errors on the Pfeiffer Questionnaire (SPMSQ) to detect cognitive
impairment in older adults will be included in the study.
- Intervention errors: It will be ensured that each participant receives one daily dose of
the placebo or treatment in the same quantity, presentation, texture, smell, and taste
to ensure masking. To avoid any contingencies where the product provider cannot continue
supplying the treatment, all doses will be packaged, labeled, and properly identified
for the 6-week intervention period from the start of the intervention. This means that
each participant will be guaranteed the assignment of placebo or treatment for the six
weeks according to the respective group. To prevent data loss from measurements, a
backup will be stored in the institutional OneDrive of the University CES immediately
after each data collection.
- Attrition control: The possibility of voluntary withdrawal from the study by the
participating older adults is acknowledged. This attrition risk will be pre-controlled
by increasing the sample size by 10% of the required value in both groups, so that the
dropout of any participant does not affect the completion of the research due to missing
data in the results. The principal investigator will conduct telephone follow-up with
the long-term care facilities to evaluate participant retention. A face-to-face visit
will be conducted in the third week to inquire about participants' satisfaction and
perceptions.
Analysis Strategy
The primary analysis set will be the intention-to-treat (ITT) population, including every
participant randomized with at least one post-intervention observation. In the ITT analysis,
study subjects are compared within the groups they were originally assigned to, randomly. In
more depth, this implies analyzing and including all patients regardless of whether they
received the full treatment or withdrew or deviated from the originally established protocol.
This means that patients will be analyzed as they were randomized, whether they complete the
study or not (90).
Data Analysis
After preparing the database, the following analysis plan will be conducted, where variables
will be addressed according to their relationship with the project's objectives, involving
descriptive and analytical processing.
- Descriptive statistics will be performed based on normality tests and absolute and
relative frequencies.
- Within-group comparison before and after the intervention will be conducted to determine
if there are differences in the number of spontaneous evacuations. The statistical tests
for this analysis will be parametric or non-parametric, depending on the distribution of
the variable. The paired t-test or Wilcoxon test will be considered in this regard.
Cohen's d or r-value will be used for effect size calculation for paired t-test or
Wilcoxon, respectively.
- Between-group comparison at the end of the intervention will be conducted to determine
if there are differences in the quality of life index. The statistical tests for this
analysis will be parametric or non-parametric, depending on the distribution of the
variable. The t-test or Mann-Whitney U test will be considered. Tau-b, Cliff's delta, or
Cohen's d will be used for effect size calculation.
- Within-group comparison before and after the intervention will be conducted to determine
if there are differences in the quality of life index. The statistical tests for this
analysis will be parametric or non-parametric, depending on the distribution of the
variable. The paired t-test or Wilcoxon test will be considered. Cohen's d or r-value
will be used for effect size calculation for paired t-test or Wilcoxon, respectively.
- Between-group comparison at the end of the intervention will be conducted to determine
if there are differences in the proportions of satisfactory relief. In this regard, the
Pearson chi-square test will be considered. Phi (φ) or Cramer's V will be used for
effect size calculation.
