SH-DS01 on Fecal Metagenomic Stability

This is an interventional treatment trial for Irritable Bowel Syndrome Read More

Inclusion Criteria:

• Patient must be willing and able to give informed assent/ consent for participation in the study
• Patient must be willing and able (in the PI's opinion) to comply with all study requirements.
• Patient must be a premenopausal female or male aged 18 and older.
• Patient must have a documented history of IBS that is not completely controlled by current IBS drugs.
• Patient must have a score of ≥150 on the IBS-SSS at screening.
• Patient must have no clinically relevant (in the judgment of the PI) abnormal blood laboratory levels at screening or randomization.
• The clinician will assess eligibility as per the Rome IV criteria (Recurrent abdominal pain or discomfort at least 1 day/week in the last 3 months associated with two or more of the following: Improvement with defecation. Onset associated with a change in frequency of stool).

Exclusion Critieria:

• Patient has clinically significant unstable medical conditions other than IBS.
• Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization.
• Patient has clinically significant laboratory values (in the PI's opinion).
• Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) or supplements (including hemp oil/extracts) within one month prior to study entry and is unwilling to abstain for the duration for the study.
• Patient has consumed any probiotic product three days prior to screening and/or is unwilling to abstain from consuming these during the study.
• Intake of antibiotics in the past 1-month (i.e. penicillin, amoxicillin, cephalexin (Keflex), erythromycin (E-Mycin), clarithromycin (Biaxin), azithromycin (Zithromax), ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin (Floxin), co-trimoxazole (Bactrim), trimethoprim (Proloprim), tetracycline (Sumycin or Panmycin), doxycycline (Vibramycin), gentamicin (Garamycin), or tobramycin (Tobrex). The supplement in the present study may have a minor interaction with these medications.
• Patient has any known or suspected hypersensitivity to pomegranate, pine, or mushrooms, or any of the excipients of the Supplement Synbiotic Product (SSP).
• Patients of child bearing potential unless willing to ensure that they use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter.
• Patients who are pregnant, lactating, or planning pregnancy during the course of the study and for three months thereafter.
• Patients who have been part of a clinical trial involving any investigational product in the previous six months.
• Any other significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study.
• Patient has significantly impaired hepatic function at Visit 1 (Alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or bilirubin >2 × ULN) OR the ALT or Aspartate aminotransferase (AST) >3 × ULN and the bilirubin >2 × ULN (or international normalized ratio >1.5).
• Obesity (BMI > 30)
• Implantable device such as heart pacemaker.
• Patients unwilling to abstain from donation of blood during the study.
• History of inflammatory bowel disease.
• History of diverticulosis.
• History of cardiovascular disease.
• History of kidney/liver/serious infection.
• History of diabetes or other hormone diseases.
• History of abdominal surgery.
• Currently suffering from high blood pressure.
• Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
• There are plans for the patient to travel outside the USA during the study.