N/A
N=4
Dietary Soy Isoflavones In Chronic Pancreatitis
Chronic Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02577640 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soy bread (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jul 2017
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 | — |
Summary
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease
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.