Effects of Synbiotics on FC and Other Contributing Factors (NCT04620317) | Clinical Trial Compass
CompletedNot Applicable
Effects of Synbiotics on FC and Other Contributing Factors
85 participantsStarted 2015-01
Plain-language summary
Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p \< 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.
Who can participate
Age range
18 Years – 65 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:
* Malaysian of either gender;
* 18 to 65 years old;
* Body mass index (BMI) 16.0 to 29.9 kg/m2;
* Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist
Exclusion Criteria:
* Vulnerable groups of pregnant and breastfeeding women;
* Physically or mentally handicapped individuals;
* Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
* Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
* Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.
To avoid the likelihood of co-intervention bias, the following respondents were excluded:
* On gastrointestinal medications;
* Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period;
* Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.
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.
What they're measuring
1
Defecation frequency
Timeframe: 16 weeks
2
Stool types - Bristol Stool Form (BSF) Scale
Timeframe: 16 weeks
3
Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)