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

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID: NCT04491734
Run by: ISOThrive Inc.
People needed: 156
Starts: 2020-06-01
Expected to finish: 2021-08-26
Last updated by the study team: 2021-08-30

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
Participation in a rigorous weight loss program or have any planned changes in diet or lifestyle, such as getting married, change in residence, change in job, or other highly stressful event
Diagnosis of inflammatory bowel disease, irritable bowel syndrome, or chronic diarrhea (mild chronic constipation is allowed)
Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.
An investigator, key study personnel or first degree relative of anyone involved with the study
Other conditions or situations that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Where it is running

ISOThrive Inc. — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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