Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Hear… (NCT05363618) | Clinical Trial Compass
CompletedNot Applicable
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
United States211 participantsStarted 2022-02-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
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.
What they're measuring
1
Tolerability as recorded via RESQ-eD (online PRO) questions
. 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