Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease

NCT04491734 | Completed

• 1 other identifier: 1001
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101. In addition, usage of the ReQuest validated questionnaire to measure GERD symptoms will be explored as well as usage of the validated SF-36 quality of life (QoL) questionnaire. Each subject serves as his/her own control. Relative tolerability in subjects both on and off proton pump inhibitors (PPIs) will be compared. Subjects naive to PPIs, currently taking PPIs and historically on PPIs will be evaluated with ReQuest and QoL scores. In addition, survey measurements will be taken on a subset of 10 subjects that are non-responders to PPIs. These will not be included in the statistical analysis with the above groups. A tertiary endpoint of this study is to assess any relevant adverse events that occur.

Conditions

Gastroesophageal Reflux

Keywords

GERD; reflux; remote; PPI

Outcome Measures

Primary Outcomes (3)

• Tolerability of ISOT-101 using GERD ReQuest Short Version

  Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention score using GERD ReQuest Short Version. The scores for weeks 1, 2, 3, and 4 will be compared with baseline. With regard to the ReQuest Short Version questionnaire, the range is 0 to 46.28 with higher numbers reflecting more severe symptoms. Tolerability is defined as the post-intervention score is equal to or less than baseline.

  4 weeks

• Tolerability of ISOT-101 using GERD ReQuest Long Version

  Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention scores using GERD ReQuest Long Version. The scores for weeks 1, 2, 3, and 4 will be compared with baseline. With regard to the ReQuest Long Version, the range is 0 to 46.28 with higher numbers reflecting more severe symptoms. Tolerability is defined as the post-intervention score is equal to or less than baseline.

  4 weeks

• Tolerability of ISOT-101 using Rand Short Form-36 (v1.0)

  Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention scores using Rand Short Form-36 (v1.0). The scores for weeks 1, 2, 3, and 4 will be compared with baseline. The range of the SF-36 scoring is 0-100 with higher numbers defining a more favorable health state. Tolerability is defined as the post-intervention score is equal to or greater than baseline.

  4 weeks

Secondary Outcomes (1)

• Measure adverse events

  4 weeks

Study Arms (1)

Tolerability Arm

OTHER

Single arm study of active study product

Dietary Supplement: maltosyl-isomalto-oligosaccharides (MIMO)

Interventions

maltosyl-isomalto-oligosaccharides (MIMO) DIETARY_SUPPLEMENT

Digestion-resistant carbohydrate, ISOT-101, a specific formulation of maltosyl-isomalto-oligosaccharides (MIMO), that serves as a prebiotic, feeding selected bacteria that commonly inhabit the human GI tract.

Tolerability Arm

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking male and female adults between the ages of 25 and 75, inclusive
• Body mass index (BMI) \<35 and \>19
• Either 3.a. or 3.b. or both, based on the Screening Phase ReQuest Short and Long Version responses:
• At least one incidence of (a) acid complaints; (b) upper abdominal/stomach complaints and RQ Total score \>3.37 or RQ-GI score \>0.95
• Four days or more of combined incidence of (a) acid complaints; (b) upper abdominal/stomach complaints.
• History (minimum of three months) of GERD symptoms as defined in #3 above
• Must be on stable doses of medications, if any, prescribed for chronic conditions other than GERD
• If female, must be on an active contraceptive measure or have male partner(s) with suitable protective measures
• 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
• Ability and willingness to give consent to participate in study

You may not qualify if:

• Significant comorbidities that are not medically stable
• History of scleroderma, diabetes, Barrett's esophagus, esophageal cancer, esophageal stricture, or esophageal scarring (fibrosis)
• Known hiatal hernia \> 2cm
• Positive diagnosis for Helicobacter pylori (HP) or has had an HP infection within 45 days of study entry
• 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
• BMI \>=35, BMI \<=19
• History of diseases that have symptoms that may be confused with GERD, such as eosinophilic esophagitis, angina, gastritis, esophageal spasm, rumination, or other conditions involving the mouth, throat, chest or abdomen
• Active history of nicotine use, cannabis use or alcohol abuse (as defined by: greater than 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 in the last 6 months or has abused alcohol in the last 6 months
• Taking any excluded medications listed in the protocol (e.g. metformin, antibiotics within the prior 6 months.)
• If female, is pregnant, lactating, or intending to become pregnant before, during or within 4 weeks after participating in this study or intending to donate ova during such time period
• Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia
• Colon prep within 30 days prior to study entry
• Use of any investigational product within 90 days prior to study entry
• Participation in another investigation (clinical trial) during the course of this study

Sponsors & Collaborators

• ISOThrive Inc.: lead

Study Sites (1)

ISOThrive Inc.

Manassas, Virginia, 20109, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• John Selling, MD

  ISOThrive Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 29, 2020
• Study Start: June 1, 2020
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)