An interventional study of Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) and Placebo 1.4 ml in Heartburn, sponsored by Microbiome Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Microbiome Health Sciences · Not applicable, Interventional, and Other
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.
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.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's enrollment of 211 is above the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →Microbiome Health Sciences is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Screening Phase inclusion, subjects must meet all the following inclusion criteria to be eligible for enrollment into the study:
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:
Exclusion Criteria:
Subject has any acute or chronic illness that could confound outcome assessments for this study, including, but not limited to:
Subject has any known medical condition, clinical signs and symptoms, vital signs, abnormal laboratory, or other testing, considered by the Investigator, that could interfere with the subject's participation in and completion of the study including, but not limited to:
Subject has had surgery that meets any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Product MHS-1031 1g (1.4 ml) per day
Dietary Supplement: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
Placebo (Neotame 7.92 mcg/g, phosphoric acid, and sterile water) 1.4 ml per day
Other: Placebo 1.4 ml
Active study product
Placebo
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in May 2023, 15 months.
Of 26 interventional studies with no phase under Heartburn, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 15 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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