A Study of the Effect of SYN-010 on Subjects With IBS-C
Launched by THERIVA BIOLOGICS, INC. · Jul 10, 2015
Trial Information
Current as of July 23, 2025
Completed
Keywords
ClinConnect Summary
This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study \[EOS\] visit telephone call).
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects must have IBS-C and have a positive breath CH4 test result (\> 10 ppm) at Screening.
- • Subject must meet the modified Rome III criteria for IBS-C.
- • Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10) reported at Screening and Baseline.
- • Subject must have an average of fewer than 3 complete spontaneous bowel movement (CSBMs) per week.
- • Subject must agree to refrain from making any lifestyle changes that may affect IBS-C symptoms from the time of Screening to the end of the study.
- Exclusion Criteria:
- • Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics.
- • Subject currently has any structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility, or any unexplained and clinically significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection.
- • Subject has been diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
- • Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale \[BSFS\] score of 6 or 7).
About Theriva Biologics, Inc.
Theriva Biologics, Inc. is a pioneering biopharmaceutical company focused on developing innovative therapies for patients with unmet medical needs in the areas of cancer and autoimmune diseases. Leveraging advanced biologic platforms and a commitment to scientific excellence, Theriva aims to transform treatment paradigms through the discovery and development of targeted therapeutics. The company's robust pipeline reflects its dedication to improving patient outcomes by harnessing the power of the immune system and novel drug delivery systems. With a strong emphasis on clinical research and collaboration, Theriva Biologics is poised to make a significant impact in the biopharma landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Patients applied
Trial Officials
Michael Kaleko, M.D.
Study Director
Synthetic Biologics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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