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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02577640 |
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Date of registration:
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07/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dietary Soy Isoflavones In Chronic Pancreatitis
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Scientific title:
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Dietary Soy Isoflavones In Chronic Pancreatitis |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02577640 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Philip Hart, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ohio State Wexner Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of chronic pancreatitis by fulfilling one of the following clinical
scenarios:
1. Presence of pancreatic calcifications
2. Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3
abnormal side branches on pancreatic duct imaging
3. Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine
pancreatic insufficiency (EPI)
2. Age =18 years
Exclusion Criteria:
1. Inability to provide written consent
2. Inability to comply with the study protocol
3. Soy allergy
4. Pancreatic cancer
5. History of prior pancreatic surgery (this does not include endoscopic therapies)
6. Comorbid diseases characterized by a chronic inflammatory state, including, but not
limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy
7. Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Pancreatitis
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Intervention(s)
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Dietary Supplement: Soy bread
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Primary Outcome(s)
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Evaluation of soy bread tolerability
[Time Frame: 1 or 4 weeks]
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Secondary Outcome(s)
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Pro-inflammatory cytokines
[Time Frame: 1 or 4 weeks]
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Secondary ID(s)
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2014H0226
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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