Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathi… (NCT05129618) | Clinical Trial Compass
CompletedNot Applicable
Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)
United States172 participantsStarted 2021-09-23
Plain-language summary
This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase) to Week 8 (Day 56). The primary analysis will be conducted to assess the tolerability of MHS 1031 product and of the formulated placebo in randomized subjects with CIC diagnosed according to a modified Rome IV criteria.
Who can participate
Age range
18 Years – 75 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
. Subject is willing and able to participate in the study for the required duration, understand and provide signed informed consent, and agrees to undergo all protocol activities.
. Subject is proficient in reading, writing, and speaking English.
. Subject is able to complete all required electronic Daily Bowel Movement and Symptoms Questionnaire, daily medication reconciliation surveys (Screening, Product Phase, and Product/Placebo Phase), bi-weekly PAC-SYM and PAC QOL questionnaire, and monthly Study Participant Global Assessment questionnaire entries during the 2 week Screening Phase assessment period and for the duration of the study (ie, the 8 week randomized Product/Placebo Phase, 4 week open label Product Phase and the 2 week Follow up Phase).
. Males or females between 18 and 75 years of age (inclusive), with a BMI ≥ 19 and \< 35 kg/m2. Females must not be pregnant or lactating.
. Female Subjects of non childbearing potential whether surgically sterile or postmenopausal.
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 as assessed using a PRO questionnaire, a 4 question Daily BM Questionnaire
. Females who are still menstruating must be able to differentiate the abdominal symptoms associated with CIC from those associated with their menses (otherwise protocol assessments of these symptoms may be confounded).
. Male and female Subjects of childbearing potential must agree to use adequate contraception from the time of informed consent to 2 weeks after receiving the last dose of study product.
. Subject meets the Rome IV functional constipation criteria as modified for this study for ≥ 3 months prior to the Screening Call. The Rome IV criteria as modified for this study, requires the following:
Exclusion criteria
. Subject has not maintained a stable diet for ≥ 30 days prior to the Screening Call or is unwilling to maintain a stable diet during the study.
. Subject has had a surgical procedure requiring general anesthesia \< 60 days before the Screening Call.
. Subject has had a colonoscopy in the past 30 days or is scheduled for colonoscopy within the next 4 months and is unable/unwilling to postpone until the completion of study participation.
. Subject has a history of cancer (other than basal cell carcinoma of the skin) unless the malignancy has been in a complete remission without maintenance therapy (eg, chemotherapy, radiation, surgery) for ≥ 5 years prior to the Screening Call.
. Subject has any acute or chronic concomitant illness that could confound outcome assessments for this study, including, but not limited to:
. Known history of ulcerative colitis, Crohn's disease, colon cancer, current stomach ulcers, pancreatitis, diverticulitis.
. Known history of acute or chronic HBV, HCV, or HIV infection.
. Known or suspected alcoholism, drug addiction, or significant drug abuse within 1 year of the Screening Call.