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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT05556824

Run by

Microbiome Health Sciences

People needed

255

Starts

2023-03-03

Expected to finish

2026-05-27

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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).
• Subject has maintained a stable diet and exercise regimen for ≥ 30 days prior to the Screening Call and is willing to maintain that diet and exercise regimen for the duration of the study (i.e., if subject is currently following diets including, but not limited to, Keto, FODMAP, Vegan, Vegetarian, s/he must be willing to continue this dietary lifestyle through end-of-study visit).

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).
• Known or suspected alcoholism, drug addiction, or significant drug abuse within 1 year of the Screening Call based on subject reporting and PI assessment.
• Active history of tobacco or nicotine use (of any type) in the last 6 months averaging more than 1 cigar/cigarette per week. Vaping products and e-cigarettes that contain nicotine and/or tobacco are not allowed. Chewing tobacco and nicotine gum are prohibited at any level. Nicotine patches are NOT exclusionary.
• Alcohol abuse (for alcohol defined as: > 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women).
• Intake of acetylsalicylic acid (i.e., aspirin) at doses > 162 mg/day.
• Non-steroidal anti-inflammatory pain relievers (NSAIDs) such as ibuprofen (Advil®, Motrin® IB, others) >/= 4 days/week on average not to exceed half the recommended maximum prescription daily dosing as listed in the Physician's Desk Reference.
• Acetaminophen > 2,000 mg/day
• Inhalation or ingestion of products containing delta-9-tetrahydrocannabinol (THC) > 2 days/week on average.
• Any known medical condition, clinical signs and symptoms, vital signs, abnormal laboratory, or other testing that are not well controlled on stable dosing of medication for at least 90 days prior to the Screening Call or are considered clinically significant by the Principal Investigator (PI), that could interfere with the subject's participation in and completion of the study. Examples of medical conditions including, but not limited to:
• Uncontrolled hypertension
• Uncontrolled diabetes

Where it is running

• Elite Clinical Studies LLC — Phoenix, Arizona, United States
• Angel City Research — Los Angeles, California, United States
• Wr-Msra, Llc — Lake City, Florida, United States
• A Positive Clinical Research — Miami, Florida, United States
• Advanced Gastroenterology Associates LLC — Palm Harbor, Florida, United States
• Health Synergy Clinical Research — West Palm Beach, Florida, United States
• West Palm Quality Research (WPQR) — West Palm Beach, Florida, United States
• EmVenio-Georgia (EMGA) — Atlanta, Georgia, United States
• WR-Mount Vernon Clinical Research (MVCR) — Sandy Springs, Georgia, United States
• Gastroenterology Associates of Western Michigan PLC (WMCR) — Wyoming, Michigan, United States
• M3 Wake Research (CPOR) — Raleigh, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• SMS Clinical Research (SMSR) — Mesquite, Texas, United States
• A and U Family Medicine (NCR) — Sugar Land, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Charlottesville Medical Research Center — Charlottesville, Virginia, United States
• Digestive Disease and Liver Specialists — Norfolk, Virginia, United States
• GI Research Partners, LLC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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