A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constip… (NCT02073006) | Clinical Trial Compass
CompletedPhase 2/3
A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation
Ireland70 participantsStarted 2014-02
Plain-language summary
Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment.
This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility.
The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.
Who can participate
Age range
18 Years – 80 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
. Be able to give written informed consent,
. Be between 18 and 80 years of age,
. Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory.
. Straining during at least 25% of defæcations
. Lumpy or hard stools in at least 25% of defæcations
. Sensation of incomplete evacuation for at least 25% of defæcations
. Sensation of anorectal obstruction / blockage for at least 25% of defaecations
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.
. Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor)
Exclusion criteria
. Are less than 18 and greater than 80 years of age,
. Females are pregnant, lactating or wish to become pregnant during the study.
. Are hypersensitive to any of the components of the test product,
. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
. Subject has an obstructive or metabolic aetiology for constipation,
. Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
. Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit,
. Subject has a history of drug and/or alcohol abuse at the time of enrolment