Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05556824
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-09-21
Brief Title:
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
Sponsor:
Microbiome Health Sciences
Organization:
Microbiome Health Sciences
Study Overview
Official Title:
A Multi-Center Study of Panosyl-Isomaltooligosaccharides PIMO Adjunctive to Proton Pump Inhibitor PPI Therapy to Treat Gastroesophageal Reflux Disease GERD in Subjects Who Are PPI-Responders or PPI-Partial Responders
Status:
RECRUITING
Status Verified Date:
2024-08
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 study will be conducted as a multi-center randomized double-blind placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn-free days in subjects with GERD-related heartburn symptoms
Detailed Description:
MHS-1031 is a specific proprietary digestion-resistant oligosaccharide carbohydrate that serves as a prebiotic The active ingredient in MHS- 1031 is a well-defined and well-characterized distribution of panosyl-isomaltooligosaccharides PIMOs ranging in degree of polymerization DP from DP3 to DP8
This study will be conducted as a multi-center randomized double-blind placebo-controlled trial to evaluate the effect of MHS-1031 adjunctive to PPI therapy on heartburn-free days in subjects with GERD-related heartburn symptoms who self-report improvement while on sustained daily PPI therapy Heartburn-free days will be determined by subject report specific to any of the three questions burning feeling behind the breastbone andor pain behind your breastbone andor heartburn Questions 1 2 3 of the RESQ-eD For purposes of this trial heartburn-free days are defined as subject report of Did Not Have or Very Mild on each of the three RESQ-eD questions listed above
All candidate subjects must self-report at least partial response to sustained daily PPI acid suppressive therapy ie daily defined as taking PPIs 5-7 daysweek on average Candidate subjects will be screened for medical history of chronic heartburn that may be associated with other medical conditions and these subjects will be excluded The entire study consists of three phases Remote Screening Phase 2-Week Assessment SP1 on-site Screening Phase Part 2 SP2 and Treatment Phase TP
Efficacy will be assessed using patient reported outcome PRO questionnaires concomitant medication assessments and assessment of adverse events from baseline determined during Remote Screening Phase 2-Week Assessment to Treatment Phase Weeks 1-4 and Weeks 5-8 The primary analyses will be conducted to assess the efficacy of MHS-1031 adjunctive to PPI therapy and separately as monotherapy subsequent to combined PPI and MHS-1031 therapy in randomized subjects with GERD-related heartburn as determined by the RESQ-eD validated questionnaire validated for use online
This study will be conducted as a multi-center randomized double-blind placebo-controlled trial to evaluate the effect of MHS-1031 adjunctive to PPI therapy on heartburn-free days in subjects with GERD-related heartburn symptoms who self-report improvement while on sustained daily PPI therapy Heartburn-free days will be determined by subject report specific to any of the three questions burning feeling behind the breastbone andor pain behind your breastbone andor heartburn Questions 1 2 3 of the RESQ-eD For purposes of this trial heartburn-free days are defined as subject report of Did Not Have or Very Mild on each of the three RESQ-eD questions listed above
All candidate subjects must self-report at least partial response to sustained daily PPI acid suppressive therapy ie daily defined as taking PPIs 5-7 daysweek on average Candidate subjects will be screened for medical history of chronic heartburn that may be associated with other medical conditions and these subjects will be excluded The entire study consists of three phases Remote Screening Phase 2-Week Assessment SP1 on-site Screening Phase Part 2 SP2 and Treatment Phase TP
Efficacy will be assessed using patient reported outcome PRO questionnaires concomitant medication assessments and assessment of adverse events from baseline determined during Remote Screening Phase 2-Week Assessment to Treatment Phase Weeks 1-4 and Weeks 5-8 The primary analyses will be conducted to assess the efficacy of MHS-1031 adjunctive to PPI therapy and separately as monotherapy subsequent to combined PPI and MHS-1031 therapy in randomized subjects with GERD-related heartburn as determined by the RESQ-eD validated questionnaire validated for use online
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None