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Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)

NCT05129618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-07-18

No results posted yet for this study

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.

Conditions

  • Constipation Chronic Idiopathic

Interventions

DIETARY_SUPPLEMENT

MHS 1031

prebiotic syrup in individual sachets containing 1g (1.4 ml) of panosyl-isomaltooligosaccharides

OTHER

placebo

liquid combination formulation of Neotame 7.92 mcg/g, phosphoric acid, and sterile water, designed to have the same degree of sweetness as the test material, provided in individual sachets containing 1.4 ml.

Sponsors & Collaborators

  • Microbiome Health Sciences

    lead INDUSTRY

Principal Investigators

  • Peter Swann, MD · Microbiome Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2022-06-12
Completion
2022-06-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129618 on ClinicalTrials.gov