Effects of MSPrebiotic on Gut Health in the Elderly (NCT01977183) | Clinical Trial Compass
CompletedNot Applicable
Effects of MSPrebiotic on Gut Health in the Elderly
Canada84 participantsStarted 2013-09
Plain-language summary
The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied.
Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet.
Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.
Who can participate
Age range
30 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:
* Ability to provide written informed consent
* Willing to provide stool and blood specimens 5 times over the 14 week study period
* Subjects ≥ 70 years of age
* Subjects 30-50 years of age
Exclusion Criteria:
* Pregnancy
* Crohn's disease or any other inflammatory bowel disease
* Individuals with Lupus, or on cancer chemotherapy
* Pre-diabetes or Diabetes
* Thyroid disease
* Renal disease
* Hepatic disease
* Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
* Subjects on probiotic
* Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
* Individuals experiencing dysphagia
* Subjects using additional fiber supplements
* Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
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
Tolerability of 30g dose of MSPrebiotic
Timeframe: 2, 6, 10 and 14 weeks
2
Gut health improvements
Timeframe: 2, 6, 10 and 14 weeks
3
Levels of short chain fatty acids in stool and lipid level in blood