HeartburnNCT05363618
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
A study testing Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) in people with Heartburn, run by Microbiome Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heartburn
- What is being tested?
- Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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).
Who cannot join
- 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.
Show all 51Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Microbiome Health Sciences
Manassas, Virginia, 20109
About this study
Official title: A Parallel Randomized, Blinded, Un-controlled Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo, in Subjects With Heartburn
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.
Read the 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.
- Conditions
- Heartburn
- Being tested
- Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml), Placebo 1.4 ml
- Keywords
- Heartburn, microbiome, acid reflux, PIMO, indigestion
- Medical subject headings
- Heartburn, Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)Dietary supplement
Active study product
Placebo 1.4 mlOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Product Tolerability Arm | Active comparator | Study Product MHS-1031 1g (1.4 ml) per day Receives: 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 Receives: Other: Placebo 1.4 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start10 Feb 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbiome Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Swann, MD, Principal investigator, Microbiome Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363618
- Sponsor's protocol ID
- MHS-1031-03
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Randomized, Blinded, Un-controlled Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo, in Subjects With Heartburn
- ClinicalTrials.gov ID
- NCT05363618
- Acronym / sponsor ID
- MHS-1031-03
- Conditions
- Heartburn
- Keywords
- Heartburn, microbiome, acid reflux, PIMO, indigestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Microbiome Health SciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Product Tolerability Arm | Active comparator | Dietary Supplement: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)Study Product MHS-1031 1g (1.4 ml) per day |
| Placebo Tolerability Arm | Placebo comparator | Other: Placebo 1.4 mlPlacebo (Neotame 7.92 mcg/g, phosphoric acid, and sterile water) 1.4 ml per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (51 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)Active study product | Dietary supplement | Product Tolerability Arm |
| Placebo 1.4 mlPlacebo | Other | Placebo Tolerability Arm |
Primary outcome
Tolerability as recorded via RESQ-eD (online PRO) questions
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Swann, MD principal investigator
Microbiome Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) in people with Heartburn, run by Microbiome Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability as recorded via RESQ-eD (online PRO) questions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.