CLINICAL TRIAL

Treatment for Heartburn

Recruiting · 18+ · All Sexes · Manassas, VA

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

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About the trial for Heartburn

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
DIETARYSUPPLEMENT
Control Group 2
Placebo 1.4 ml
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
You are female and surgically sterile or postmenopausal. show original
omeprazole (no more than 40 mg/day)
You are willing and able to participate in the study for the required duration, understand and provide signed informed consent, and agree to undergo all protocol activities. show original
You are female and you are of childbearing potential show original
You are on stable doses of medications, if any, prescribed for chronic conditions. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8 weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Heartburn. Measurement will happen over the course of 8 weeks.

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.

Patient Q & A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Heartburn by sharing your contact details with the study coordinator.