Clinical Trials Logo
  1. Home
  2. Heartburn
  3. NCT05363618

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

Heartburn Clinical Trial

Official title:
A Parallel Randomized, Blinded, Un-controlled Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo, in Subjects With Heartburn

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05363618
Study type Interventional
Source Microbiome Health Sciences
Contact
Status Completed
Phase N/A
Start date February 10, 2022
Completion date May 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT00481949 - Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Recruiting NCT02105090 - Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy Phase 4
Completed NCT01338077 - Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease Phase 3
Completed NCT01005251 - Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI Phase 2
Terminated NCT00536328 - What is the Predictive Value of the Reflux Impact Scale N/A
Completed NCT00382577 - Efficacy and Safety of Itopride vs Placebo in Heartburn Phase 3
Completed NCT00236197 - E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236184 - E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236392 - A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD) Phase 3
Completed NCT04153552 - Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn N/A
Recruiting NCT06075082 - The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms. N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Recruiting NCT02277886 - Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances Phase 4
Completed NCT01249651 - To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole Phase 4
Completed NCT00588939 - Confocal Laser Microscopy in Non Erosive Reflux Disease N/A
Completed NCT00206024 - Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Phase 4
Recruiting NCT05976165 - A Study of Breath Testing for Small Intestinal Bacterial Overgrowth N/A