Clinical trial: Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease (NCT04491734)

Eligibility criteria:
Inclusion Criteria:

          1. English-speaking male and female adults between the ages of 25 and 75, inclusive

          2. Body mass index (BMI) <35 and >19

          3. Either 3.a. or 3.b. or both, based on the Screening Phase ReQuest Short and Long
             Version responses:

               1. 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

               2. Four days or more of combined incidence of (a) acid complaints; (b) upper
                  abdominal/stomach complaints.

          4. History (minimum of three months) of GERD symptoms as defined in #3 above

          5. Must be on stable doses of medications, if any, prescribed for chronic conditions
             other than GERD

          6. If female, must be on an active contraceptive measure or have male partner(s) with
             suitable protective measures

          7. 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

          8. Ability and willingness to give consent to participate in study

        Exclusion Criteria:

          1. Significant comorbidities that are not medically stable

          2. History of scleroderma, diabetes, Barrett's esophagus, esophageal cancer, esophageal
             stricture, or esophageal scarring (fibrosis)

          3. Known hiatal hernia > 2cm

          4. Positive diagnosis for Helicobacter pylori (HP) or has had an HP infection within 45
             days of study entry

          5. History of surgery or endoscopic treatment including fundoplication and dilation for
             esophageal stricture

          6. History of gastric surgery (except for endoscopic removal of benign polyps) or
             bariatric surgery

          7. BMI >=35, BMI <=19

          8. 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

          9. 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

         10. Taking any excluded medications listed in the protocol (e.g. metformin, antibiotics
             within the prior 6 months.)

         11. 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

         12. Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia

         13. Colon prep within 30 days prior to study entry

         14. Use of any investigational product within 90 days prior to study entry

         15. Participation in another investigation (clinical trial) during the course of this
             study

         16. 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

         17. Diagnosis of inflammatory bowel disease, irritable bowel syndrome, or chronic diarrhea
             (mild chronic constipation is allowed)

         18. Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.

         19. An investigator, key study personnel or first degree relative of anyone involved with
             the study

         20. 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction