Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD

NCT05556824 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: MHS-1031-04
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 18

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.

Conditions

Gastroesophageal Reflux

Keywords

GERD; microbiome; PIMO; PPI; Heartburn; Gastroesophageal Reflux; Prebiotic

Outcome Measures

Primary Outcomes (1)

• Heartburn-free days/week

  The difference between baseline weekly average heartburn-free days and weekly average heartburn-free days during Treatment Phase Weeks 1-4 and Weeks 5-8 (as measured using questions 1, 2 and 3 of the Reflux Symptom Questionnaire Electronic Diary) (RESQ-eD).

  4 and 8 weeks

Secondary Outcomes (3)

• Heartburn symptom severity

  4 and 8 weeks

• Heartburn-free day satisfaction

  4 and 8 weeks

• GERD-related severity satisfaction

  4 and 8 weeks

Study Arms (2)

Drug Product

ACTIVE COMPARATOR

Panosyl-isomaltooligosaccharide (PIMO) liquid 1 g (1.5 ml) per day for 8 weeks

Drug: MHS-1031

Placebo

PLACEBO COMPARATOR

Placebo liquid (1.5 ml) per day for 8 weeks

Other: Placebo

Interventions

MHS-1031 DRUG

Study medication will be supplied as a syrup in individual sachets containing 1g (1.5 mL) of MHS-1031. Subjects will be randomized in 2:1 fashion to either study drug (2) or placebo (1)

Also known as: Panosyl-isomaltooligosaccharide

Drug Product

Placebo OTHER

Matching placebo is an oral solution formulated to have a degree of sweetness and acidity similar to the study medication and will be provided in equivalent sachets containing 1.5g (1.5 mL) of the oral placebo solution.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the opinion of the investigator or sub-investigators, the subject is capable of understanding and complying with protocol requirements, including compliance with completing nightly online questionnaires in one of the IRB-approved languages.
• Subject signs and dates an electronic (Screening Phase Part 1) and site-specific written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
• Ability, during Remote Screening Phase 2-Week Assessment, to complete all required online nightly RESQ-eD questionnaires, medication questionnaires, 4-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4) questionnaire and Participant Global Assessment questionnaire.
• Access to a computer/tablet/phone with internet access and active email account in order to complete online questionnaires daily throughout study participation.
• Males or females ≥18 and ≤75 years of age, with a BMI ≥ 18 and \< 35 kg/m2.
• Female subjects must be postmenopausal or surgically sterile or, if of childbearing potential, must agree to use a medically acceptable form of contraception from the time of signing the informed consent form through completion of study. If only the barrier method is used, a single barrier or better is adequate. Postmenopausal women must have had ≥ 12 months of spontaneous amenorrhea. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. All women of childbearing potential must have a negative pregnancy test result before administration of study drug.
• Must be on stable doses of medications, if any, prescribed for chronic conditions other than GERD.
• Subject must be taking daily PPI (defined as 5-7 days/week on average) for at least four (4) consecutive weeks with self-reported symptom improvement (frequency and/or severity) prior to the Screening Call selected from the following list of medications:
• omeprazole
• esomeprazole
• lansoprazole
• dexlansoprazole
• pantoprazole
• rabeprazole
• Onset of GERD-related heartburn symptoms for a minimum of 3 months prior to Screening Call (i.e., "burning feeling behind the breastbone" and/or "pain behind your breastbone" and/or "heartburn" per questions 1, 2 or 3 of RESQ-eD).

You may not qualify if:

• Current use of any mouthwash (e.g., Listerine, Scope, others) or unwilling to discontinue use for the duration of the study (requires 3-day washout prior to starting the Remote Screening Phase 2-Week Assessment)
• Teeth whitening within 7 days of Screening Call or current use of teeth whitening substances (not including teeth whitening toothpaste) or unwilling to discontinue use for the duration of the study (requires 7-day washout prior to starting the Remote Screening Phase 2-Week Assessment).
• Current use of histamine 2 receptor antagonists (H2RAs) (requires 7-day washout prior to starting the Remote Screening Phase 2-Week Assessment).
• Surgical procedure requiring general anesthesia within 60 days of the Screening Call
• Colonoscopy, high colonic, colonic cleanse or barium enema in the past 30 days, or scheduled for colonoscopy or barium enema at any time for the duration of the study, and unwilling to postpone until after study completion.
• History of cancer diagnosis and/or treatment (other than basal cell carcinoma of the skin) within the preceding five (5) years.
• Concomitant illness with potential to confound outcome assessments for this study, including, but not limited to:
• History of untreated peptic or gastric ulcer, Zollinger-Ellison syndrome, or Helicobacter pylori (H. pylori) positivity without a history of successful treatment
• History of ulcerative colitis or Crohn's disease.
• Stomach ulcers, pancreaticobiliary disorder (e.g., gallstones bile duct stones, pancreatic stones, pancreatitis), diverticulitis symptomatic within the past 6 months.
• Acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
• Significant current morbidity of the heart, kidney, liver or lung.
• History of Long QT Syndrome
• History of Torsades de pointes (TdP)
• Current neurological or psychiatric disorder (e.g., Parkinson's, Huntington's chorea, schizophrenia, seizure, bi-polar disorder, major depressive disorder).

Sponsors & Collaborators

• Microbiome Health Sciences: lead
• VBHRC Virginia Catalyst: collaborator

Study Sites (18)

Elite Clinical Studies LLC

Phoenix, Arizona, 85018, United States

Location

Angel City Research

Los Angeles, California, 90010, United States

Location

Wr-Msra, Llc

Lake City, Florida, 32055, United States

Location

A Positive Clinical Research

Miami, Florida, 33186, United States

Location

Advanced Gastroenterology Associates LLC

Palm Harbor, Florida, 34684, United States

Location

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

Location

West Palm Quality Research (WPQR)

West Palm Beach, Florida, 33407, United States

Location

EmVenio-Georgia (EMGA)

Atlanta, Georgia, 30345, United States

Location

WR-Mount Vernon Clinical Research (MVCR)

Sandy Springs, Georgia, 30328, United States

Location

Gastroenterology Associates of Western Michigan PLC (WMCR)

Wyoming, Michigan, 49519, United States

Location

M3 Wake Research (CPOR)

Raleigh, North Carolina, 27612, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

SMS Clinical Research (SMSR)

Mesquite, Texas, 75149, United States

Location

A and U Family Medicine (NCR)

Sugar Land, Texas, 77479, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Charlottesville Medical Research Center

Charlottesville, Virginia, 22911, United States

Location

Digestive Disease and Liver Specialists

Norfolk, Virginia, 23502, United States

Location

GI Research Partners, LLC

Richmond, Virginia, 23236, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Swann, MD

  Microbiome Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 27, 2022
• Study Start: March 3, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)