Status:
COMPLETED
Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease
Lead Sponsor:
ISOThrive Inc.
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
25-75 years
Phase:
NA
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 que...
Detailed Description
Introduction and Background GERD is found in about one-third of the population of the USA. About 20 to 45 million people have been diagnosed by a doctor and have been prescribed daily acid reducing me...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04491734
Start Date
June 1 2020
End Date
August 26 2021
Last Update
August 30 2021
Active Locations (1)
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1
ISOThrive Inc.
Manassas, Virginia, United States, 20109