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

Sponsor

Microbiome Health Sciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05363618

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Dietary Supplement: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) Other: Placebo 1.4 ml	N/A

Detailed Description

This study will be conducted as a remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in two similar subject groups 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.

Screening phase: 14 days

Product/Placebo phase: 56 days. From Day 1 through Day 28 each subject will continue taking their usual daily PPI. Beginning on Day 29 and through Day 56 subjects will be requested to not take a PPI. Subjects may re-start taking a PPI at any time.

Product Phase: 28 days. All subjects will receive MHS-1031.

Follow-Up Phase: Subjects who complete the Product Phase of the study will enter into a 14-day Follow-up Phase, during which subjects will take neither placebo nor MHS-1031.

For entry into the Screening Phase, subjects must have the following history: Heartburn experienced at least 1 day per week while taking a PPI.

During the study, tolerability will be assessed via on-line validated PRO questionnaires and assessment of adverse events. Tolerability is defined as no overall worsening of heartburn measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A remote, randomized, blinded, un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in two similar subject groups with heartburn.A remote, randomized, blinded, un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in two similar subject groups with heartburn.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Parallel Randomized, Blinded, Un-controlled Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo, in Subjects With Heartburn

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Feb 10, 2023

Anticipated Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Product Tolerability Arm Study Product MHS-1031 1g (1.4 ml) per day	Dietary Supplement: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) Active study product
Placebo Comparator: Placebo Tolerability Arm Placebo (Neotame 7.92 mcg/g, phosphoric acid, and sterile water) 1.4 ml per day	Other: Placebo 1.4 ml Placebo

Arm

Intervention/Treatment

Active Comparator: Product Tolerability Arm

Study Product MHS-1031 1g (1.4 ml) per day

Dietary Supplement: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)

Active study product

Placebo Comparator: Placebo Tolerability Arm

Placebo (Neotame 7.92 mcg/g, phosphoric acid, and sterile water) 1.4 ml per day

Other: Placebo 1.4 ml

Placebo

Outcome Measures

Primary Outcome Measures

Tolerability as recorded via RESQ-eD (online PRO) questions [8 weeks]
Tolerability is defined as the proportion of subjects at day 56 with number of days reporting heartburn no greater than baseline. The number of "heartburn days" is defined as the number of days where an answer of >0 (ie, Not "0 - Did not have") is recorded for any of the RESQ-eD questions: "burning feeling behind your breastbone", "pain behind your breastbone", and "heartburn". Subjects who are missing at day 56 will be considered to have not tolerated the study product or to have not tolerated the placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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).

Exclusion Criteria:

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
History of gastric surgery (except for endoscopic removal of benign polyps) or bariatric surgery
Subject has had a barium enema within 30 days of the Screening Call
Subject has had a fecal impaction that required hospitalization or emergency room treatment within 3 months of the Screening Call
Subject has a history diagnosis of an eating disorder in the last 5 years
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
Subject has had surgery that meets any of the following criteria:
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
Subjects who have had a gastric band unless the band has been completely removed

60 days prior to the Screening Call

Open surgery of the abdomen, pelvis, or retroperitoneal structures within 6 months prior to the Screening Call
Laparoscopic appendectomy or cholecystectomy or other instrumentation of the bowel < 60 days prior to the Screening Call
Prior use of the Study Product MHS-1031
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
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
Taking any excluded medications listed in the protocol (eg, metformin, antibiotics within the prior 6 months, and during the study)
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
Use of colon prep or high colonic within 30 days prior to the Screening Call
Narcotic (eg, opiate) use within 60 days of the Screening Call
Antibiotic use within 60 days of the Screening Call
Use of any investigational product within 3 months or five half-lives (whichever is longer) prior to study entry
Participation in another investigation (clinical trial) during the course of this study
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
Diagnosis of inflammatory bowel disease, irritable bowel syndrome (IBS-D and IBSC), Chronic Idiopathic Constipation
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
Subject previously took PPIs daily for heartburn, for at least 7 consecutive days in the past, and experienced no improvement
Subject is employed by (or is a relative of an employee) or is involved in any way with Microbiome Health Sciences
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