| Eligibility |
Inclusion Criteria:
For Screening Phase inclusion, subjects must meet all the following inclusion criteria to
be eligible for enrollment into the study:
1. 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.
2. Subject is proficient in reading, writing, and speaking English.
3. 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).
4. 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.
5. Males or females between 18 and 75 years of age (inclusive), with a BMI = 19 and < 35
kg/m2.
6. Females must not be pregnant or lactating.
7. Female Subjects of non-childbearing potential whether surgically sterile or
postmenopausal
8. 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.
9. Must be on stable doses of medications, if any, prescribed for chronic conditions.
10. 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:
1. omeprazole (no more than 40 mg/day)
2. esomeprazole (no more than 40 mg/day)
3. lansoprazole (no more than 60 mg/day)
4. dexlansoprazole (no more than 60 m/dayg)
5. pantoprazole (no more than 80 mg/day)
6. rabeprazole (no more than 40 mg/day)
11. 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).
Exclusion Criteria:
1. 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.
2. Subject has had a surgical procedure requiring general anesthesia < 60 days prior to
the Screening Call.
3. 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.
4. 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.
5. Subject has any acute or chronic illness that could confound outcome assessments for
this study, including, but not limited to:
1. Known history of untreated peptic or gastric ulcer or Helicobacter pylori (H
pylori) positivity without a history of successful treatment.
2. Known history of ulcerative colitis, Crohn's disease, colon cancer, current
stomach ulcers, pancreatitis, diverticulitis
3. Known history of acute or chronic hepatitis B virus (HBV), hepatitis C virus
(HCV), or human immunodeficiency virus (HIV) infection
4. Known or suspected alcoholism, drug addiction, or significant drug abuse within 1
year of the Screening Call
6. 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:
1. Uncontrolled hypertension
2. Diabetes uncontrolled by diet (ie, requiring oral medication or insulin)
3. Previous anaphylactic reaction to any medication
4. History of adrenal disease, diabetic nephropathy, or gastroparesis
5. Uncontrolled hypothyroidism
6. Untreated mental disorder
7. Spinal cord injury
7. Subject has had a cerebrovascular event (stroke) or myocardial infarction (MI) in the
last 6 months
8. Subject has a physiologic or structural abnormality of the GI tract, or disease or
condition that can affect GI motility, or defecation
9. Subject has plans to travel outside the USA during the study period
10. Subject has a current COVID19 infection, or a history of a prior COVID19 infection
with ongoing symptoms suggestive of "Long COVID"
11. History of scleroderma, Barrett's esophagus, esophageal cancer, esophageal stricture,
or esophageal scarring
12. History of endoscopically determined erosive esophagitis of all classes (eg, LA grade
A through D)
13. Known hiatal hernia > 2cm
14. History of surgery or endoscopic treatment including fundoplication and dilation for
esophageal stricture
15. History of gastric surgery (except for endoscopic removal of benign polyps) or
bariatric surgery
16. Subject has had a barium enema within 30 days of the Screening Call
17. Subject has had a fecal impaction that required hospitalization or emergency room
treatment within 3 months of the Screening Call
18. Subject has a history diagnosis of an eating disorder in the last 5 years
19. Subject has a history of substantiated (documented by computed tomography (CT) scan or
hospitalization) diverticulitis, or any ongoing chronic condition (eg, polycystic
kidney disease, endometriosis, ovarian cysts, or other) that may be associated with
chronic abdominal pain or discomfort and might confound the assessments in this study
during the 2 years prior to the Screening Call
20. Subject has had surgery that meets any of the following criteria:
1. Gastric bypass surgery or invasive procedure for the treatment of obesity or
surgery to remove a segment of the GI tract at any time prior to the Screening
Call
2. Subjects who have had a gastric band unless the band has been completely removed
> 60 days prior to the Screening Call
3. Open surgery of the abdomen, pelvis, or retroperitoneal structures within 6
months prior to the Screening Call
4. Laparoscopic appendectomy or cholecystectomy or other instrumentation of the
bowel < 60 days prior to the Screening Call
21. Prior use of the Study Product MHS-1031
22. History of any the following diseases that can cause heartburn (ie, "burning feeling
behind the breastbone" and/or "pain behind your breastbone" and/or "heartburn" per
RESQ-eD question 1, 2, or 3): eosinophilic esophagitis, angina, esophageal spasm,
achalasia, rumination, or other conditions involving the mouth, throat, dysphagia, or
dyspnea
23. Active history of nicotine use, cannabis use, or alcohol abuse (defined as: > 14
drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women). Has
used any tobacco, nicotine, or cannabis products (of any type) in the last 6 months or
has abused alcohol in the last 6 months
24. Taking any excluded medications listed in the protocol (eg, metformin, antibiotics
within the prior 6 months, and during the study)
25. If female, is pregnant, lactating, or intending to become pregnant before or while
participating in this study or intending to donate ova during such time period
26. Use of colon prep or high colonic within 30 days prior to the Screening Call
27. Narcotic (eg, opiate) use within 60 days of the Screening Call
28. Antibiotic use within 60 days of the Screening Call
29. Use of any investigational product within 3 months or five half-lives (whichever is
longer) prior to study entry
30. Participation in another investigation (clinical trial) during the course of this
study
31. Participation in a rigorous weight loss program or have any planned changes in diet or
lifestyle, such as getting married, change in residence, change in job, or other
highly stressful event
32. Diagnosis of inflammatory bowel disease, irritable bowel syndrome (IBS-D and IBSC),
Chronic Idiopathic Constipation
33. Regular use (ie, >=4 times per month) of antibacterial mouthwash (eg, Listerine,
Scope, others) and unwilling to stop use for the duration of the study
34. Subject previously took PPIs daily for heartburn, for at least 7 consecutive days in
the past, and experienced no improvement
35. Subject is employed by (or is a relative of an employee) or is involved in any way
with Microbiome Health Sciences
36. Other conditions or situations that, in the investigator's opinion, may put the
subject at significant risk, may confound the study results, or may interfere
significantly with the subject's participation in the study
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