Open Label Tolerability Study of ISOThrive Prebiotic Nectar (MIMO) in Subjects With Constipation
NCT04677634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2022-05-05
Summary
The purpose and efficacy endpoint of this study is to assess whether subjects with constipation predominant irritable bowel syndrome (IBS-C) or chronic Idiopathic constipation (CIC) tolerate ISOThrive.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
ISOThrive Prebiotic Nectar
The test material is ISOThrive. It is an approximately 90% pure maltosyl-isomalto-oligosacchride (MIMO) prebiotic syrup produced by bacterial fermentation/bio-conversion of sucrose and maltose. It is taken 1g daily.
Sponsors & Collaborators
-
ISOThrive Inc.
lead INDUSTRY
Principal Investigators
-
John Selling, MD · ISOThrive Inc.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-14
- Primary Completion
- 2021-04-02
- Completion
- 2021-04-02
Countries
- United States
Study Locations
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