N/A
Completed N=4
Dietary Soy Isoflavones In Chronic Pancreatitis
Source: ClinicalTrials.gov NCT02577640 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Summary
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicities |
0; 0; 0; 0 | — |
| SECONDARY Pro-inflammatory Cytokines |
2.67; 7.0; 2.38; 7.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios:
- Presence of pancreatic calcifications
- Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3 abnormal side branches on pancreatic duct imaging
- Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine pancreatic insufficiency (EPI)
- Age ≥18 years
Exclusion Criteria
- Inability to provide written consent
- Inability to comply with the study protocol
- Soy allergy
- Pancreatic cancer
- History of prior pancreatic surgery (this does not include endoscopic therapies)
- Comorbid diseases characterized by a chronic inflammatory state, including, but not limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02577640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.