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

NCT05363618 | Completed

• 1 other identifier: MHS-1031-03
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Heartburn

Keywords

Heartburn; microbiome; acid reflux; PIMO; indigestion

Outcome Measures

Primary Outcomes (1)

• Tolerability as recorded via RESQ-eD (online PRO) questions

  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.

  8 weeks

Study Arms (2)

Product Tolerability Arm

ACTIVE COMPARATOR

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

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

Placebo Tolerability Arm

PLACEBO COMPARATOR

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

Other: Placebo 1.4 ml

Interventions

Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) DIETARY_SUPPLEMENT

Active study product

Product Tolerability Arm

Placebo 1.4 ml OTHER

Placebo

Placebo Tolerability Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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

Sponsors & Collaborators

• Microbiome Health Sciences: lead

Study Sites (1)

Microbiome Health Sciences

Manassas, Virginia, 20109, United States

Location

MeSH Terms

Conditions

Heartburn; Gastroesophageal Reflux; Dyspepsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Swann, MD

  Microbiome Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 6, 2022
• Study Start: February 10, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)