Efficacy and Safety of IGN-ES001 in Chronic Widespread Pain With or Without Fibromyalgia

Exclusion Criteria

• •6. Patient has negative urine test at screening visit V1 for the following drugs of abuse:
• •1. Amphetamine
• •2. Cocaine
• •3. Metamphetamine
• •4. Morphine
• •5. Tetrahydrocannabinol
• •7. Female patient is surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least two years postmenopausal or, if of childbearing potential, she is sexually abstinent or agrees to practice adequate contraceptive measures (hormonal contraceptives, intrauterine device, double-barrier method).
• •8. Patient must have completed at least 6 screening phase diary pages satisfactorily within the past 7 days before visit V2.
• •9. Median pain NRS must be ≥ 4 in at least 1 out of the 6 pain qualities and ≥ 4 in overall pain assessment. The median will be calculated from the last 7 days before visit V2 (baseline) and will serve as baseline value.
• •1. Patients without a basic and stable CWP therapy which started at least 30 days before V1 (screening) i.e. treatment-naive patients, first diagnosis.
• •2. Known allergy or intolerance to egg or egg constituents.
• •3. History of or currently active malignancy except for malignancies that were successfully treated and have had no recurrence within 5 years before screening visit V1.
• •4. Known, uncontrolled endocrine disorders, such as hypothyroidism (TSH and free T4), and diabetes mellitus (HbA1c).
• •5. Known severe hepatic, renal, respiratory, hematologic, neurologic, infectious, or immunologic disease, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, would make the patient inappropriate for participation in this trial.
• •6. Immune response modulating medication/ therapy e.g. systemic corticosteroids, antibodies other than IP (investigational product) from a period starting 90 days before visit V1 (screening).
• •7. WHO step-II and step-III opioids (except occasional use of codeine as cough medication) from a period starting 60 days before visit V1 (screening).
• •8. Intractable vomiting likely to significantly influence gastrointestinal (GI) investigational product presence.
• •9. Surgery within 60 days before visit V1 (screening) or anticipated or scheduled for the next nine weeks after visit V1 (screening).
• •10. Vaccination from a period starting 30 days prior to visit V1 (screening).
• •11. Known liver disease or evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase \[ASAT\], alanine transaminase \[ALAT\], gamma-glutamyltransferase \[GGT\], or alkaline phosphatase \[AP\] \> 3 times the upper limit of normal).
• •12. Known kidney disease or evidence of impaired renal function, i.e. estimated glomerular filtration rate (eGFR) based on serum creatinine \< 60 mL/min as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
• •13. Pregnancy or breastfeeding.
• •14. Known severe psychiatric illness (e.g. schizophrenia, major depression, anxiety disorder, obsessive compulsive disorder, panic disorder, social phobia, post-traumatic stress) or personality disorder (e.g. borderline personality). Obvious suicide risk.
• •15. Current and/ or history of known or suspected drug or substance abuse including alcohol abuse within five years before visit V1 (screening) as stated by the patient and/ or withdrawal symptoms.
• •16. Previous enrolment in this trial, or participation in any other studies involving investigational products, simultaneously or within six months prior to be screened for this trial (visit V1).
• •17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
• •18. Employee of the investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial site, as well as family members of the employees or the investigators.
• •19. Patients unable or unwilling to include yoghurt or ayran into their daily diet.
• •20. Severe diarrhea.