Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
Study NCT ID:
NCT05129618
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)
Sponsor:
Microbiome Health Sciences
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Placebo Controlled Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study will be conducted as a multicenter, randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031 and tolerability of the formulated placebo. The study consists of a screening phase to establish eligibility and baseline values, followed by 3 distinct study periods.
Subjects with CIC will be determined eligible for the study based on modified Rome IV criteria during a 2 week Screening Phase. Approximately 200 subjects with CIC who meet all eligibility criteria will be randomized in a 1:1 ratio, with equal numbers of each in each successive group of 50 subjects, to receive either MHS 1031 \[1 g (1.4 ml) per day\] or 1.4 ml of placebo (1:1) for 8 weeks (Product/Placebo Phase). Upon completion of the 8 week Product/Placebo Phase, Subjects will enter a 4 week open label Product Phase, during which all subjects will receive MHS 1031. Subjects who complete the study will enter a 2-week Follow-up Phase, during which subjects will take neither placebo nor MHS 1031.
During the study, tolerability will be assessed on the basis of Patient Reported Outcomes (PRO questionnaires), concomitant medication assessments, and assessment of adverse events. Tolerability is defined as no overall worsening of constipation measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores.
Subjects with CIC will be determined eligible for the study based on modified Rome IV criteria during a 2 week Screening Phase. Approximately 200 subjects with CIC who meet all eligibility criteria will be randomized in a 1:1 ratio, with equal numbers of each in each successive group of 50 subjects, to receive either MHS 1031 \[1 g (1.4 ml) per day\] or 1.4 ml of placebo (1:1) for 8 weeks (Product/Placebo Phase). Upon completion of the 8 week Product/Placebo Phase, Subjects will enter a 4 week open label Product Phase, during which all subjects will receive MHS 1031. Subjects who complete the study will enter a 2-week Follow-up Phase, during which subjects will take neither placebo nor MHS 1031.
During the study, tolerability will be assessed on the basis of Patient Reported Outcomes (PRO questionnaires), concomitant medication assessments, and assessment of adverse events. Tolerability is defined as no overall worsening of constipation measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: