Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn

Completed · Not applicable · Has a placebo group

Conditions studied: Heartburn

In brief

Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn. Candidates will have heartburn and be taking daily PPIs at up to twice the standard OTC or prescription dosage. Approximately 400 subjects (men and women of all races and ethnicities) will be randomly enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.

Key facts

Study ID: NCT05363618
Run by: Microbiome Health Sciences
People needed: 211
Starts: 2022-02-10
Expected to finish: 2023-05-30
Last updated by the study team: 2023-07-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

For Screening Phase inclusion, subjects must meet all the following inclusion criteria to be eligible for enrollment into the study:
Subject is willing and able to participate in the study for the required duration, understand and provide signed informed consent, and agrees to undergo all protocol activities.
Subject is proficient in reading, writing, and speaking English.
Subject is able to complete all required electronic Daily RESQ-eD questionnaires, daily medication questionnaires (Screening Phase, Product/Placebo Phase, Product Phase, and Follow-up Phase), daily General Well-being questionnaire (Screening Phase Only), 4-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4) (Screening Phase Day 14), and monthly Participant Global Assessment questionnaire (Product/Placebo Phase, Product Phase).
Have access to a computer/tablet/phone with internet access and active e-mail account in order to complete electronic surveys daily throughout study participation.
Males or females between 18 and 75 years of age (inclusive), with a BMI ≥ 19 and < 35 kg/m2.
Females must not be pregnant or lactating.
Female Subjects of non-childbearing potential whether surgically sterile or postmenopausal
Female Subjects of childbearing potential must agree to use adequate contraception from the time of informed consent to the last dose of study product or placebo.
Must be on stable doses of medications, if any, prescribed for chronic conditions.
Subject must be taking daily PPI (defined as 5 to 7 days per week) of no more than one type (see "a" through "f" below) at no more than twice the standard prescription dose for their specific PPI type, for 4 consecutive weeks prior to the Screening Call, selected from the following list of medications:
omeprazole (no more than 40 mg/day)
esomeprazole (no more than 40 mg/day)
lansoprazole (no more than 60 mg/day)
dexlansoprazole (no more than 60 m/dayg)
pantoprazole (no more than 80 mg/day)
rabeprazole (no more than 40 mg/day)
History of a minimum of 3 months of heartburn (ie, "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…

Subject has not maintained a stable diet for ≥ 30 days prior to the Screening Call or is unwilling to maintain a stable diet during the study.
Subject has had a surgical procedure requiring general anesthesia < 60 days prior to the Screening Call.
Subject has had a colonoscopy in the past 30 days or is scheduled for colonoscopy within the next 4 months and is unable/unwilling to postpone until the completion of study participation.
Subject has a history of cancer (other than basal cell carcinoma of the skin) unless the malignancy has been in a complete remission without maintenance therapy (eg, chemotherapy, radiation, surgery) for ≥ 5 years prior to the Screening Call.
Subject has any acute or chronic illness that could confound outcome assessments for this study, including, but not limited to:
Known history of untreated peptic or gastric ulcer or Helicobacter pylori (H pylori) positivity without a history of successful treatment.
Known history of ulcerative colitis, Crohn's disease, colon cancer, current stomach ulcers, pancreatitis, diverticulitis
Known history of acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
Known or suspected alcoholism, drug addiction, or significant drug abuse within 1 year of the Screening Call
Subject has any known medical condition, clinical signs and symptoms, vital signs, abnormal laboratory, or other testing, considered clinically significant by the Investigator, that could interfere with the subject's participation in and completion of the study including, but not limited to:
Uncontrolled hypertension
Diabetes uncontrolled by diet (ie, requiring oral medication or insulin)
Previous anaphylactic reaction to any medication
History of adrenal disease, diabetic nephropathy, or gastroparesis
Uncontrolled hypothyroidism
Untreated mental disorder
Spinal cord injury
Subject has had a cerebrovascular event (stroke) or myocardial infarction (MI) in the last 6 months
Subject has a physiologic or structural abnormality of the GI tract, or disease or condition that can affect GI motility, or defecation
Subject has plans to travel outside the USA during the study period
Subject has a current COVID19 infection, or a history of a prior COVID19 infection with ongoing symptoms suggestive of "Long COVID"
History of scleroderma, Barrett's esophagus, esophageal cancer, esophageal stricture, or esophageal scarring
History of endoscopically determined erosive esophagitis of all classes (eg, LA grade A through D)
Known hiatal hernia > 2cm
History of surgery or endoscopic treatment including fundoplication and dilation for esophageal stricture

Where it is running

Microbiome Health Sciences — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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