Chronic Pancreatitis
Conditions
Brief summary
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease
Detailed description
Management of pancreatic disorders imparts a major burden on healthcare costs, estimated at over 3 billion dollars annually. Chronic pancreatitis is characterized by chronic inflammation and progressive scarring, leading to abdominal pain, irreversible damage to the pancreas and the loss of both exocrine and endocrine function. Additionally, chronic pancreatic inflammation is a risk factor for pancreas cancer. There are no current treatments to modify the natural history of this disorder. Thus, identifying novel therapeutic options for this disease represents a high priority, and could fill an unmet medical need to improve quality of life, reduce risk of malignant transformation, and limit exorbitant medical costs associated with patient care. The investigators have assembled a multi-disciplinary research team to pursue an alternative, non-pharmacologic approach to limiting inflammatory cascades in (Chronic Pancreatitis) CP patients. They will assess compliance, toxicity and measure the changes in pro-inflammatory cytokine expression from a soy based dietary bread product using a classic 3+3 dose escalation study design in subjects with chronic pancreatitis.
Interventions
DIETARY_SUPPLEMENTSoy bread
Soy breads will be produced using a sponge-dough process. Finished dough will be formed, panned, and proofed in proofing cabinet (\ 95% RH) at 40ºC for 60 minutes. Proofed loaves will be baked for 50 minutes at 150ºC in a convection oven (jet air oven, model: JA14, Doyon, Liniere, Quebec, Canada). Breads will be considered done at an internal temperature of 95 ± 5ºC.
Sponsors
Ohio State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities | 1 (dose escalation groups) or 4 (maximally tolerated dose) weeks | Participants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pro-inflammatory Cytokines | 1 (dose escalation group) or 4 weeks (maximally tolerated subject) | Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Escalation Group 1 1 slice bread per day for 1 week | 4 |
| Dose Escalation Group 2 2 slices bread per day for 1 week | 3 |
| Dose Escalation Group 3 3 slices bread per day for 1 week | 1 |
| Maximally Tolerated Dose maximally tolerated dose for 4 weeks | 1 |
| Total | 9 |
Baseline characteristics
| Characteristic | Dose Escalation Group 2 | Dose Escalation Group 3 | Dose Escalation Group 1 | Maximally Tolerated Dose | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 |
Outcome results
Primary
Dose Limiting Toxicities
Participants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period.
Time frame: 1 (dose escalation groups) or 4 (maximally tolerated dose) weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation Group 1 | Dose Limiting Toxicities | 0 Participants |
| Dose Escalation Group 2 | Dose Limiting Toxicities | 0 Participants |
| Dose Escalation Group 3 | Dose Limiting Toxicities | 0 Participants |
| Maximally Tolerated Dose Group | Dose Limiting Toxicities | 0 Participants |
Secondary
Pro-inflammatory Cytokines
Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread
Time frame: 1 (dose escalation group) or 4 weeks (maximally tolerated subject)
Population: For the purposes of analyzing the secondary outcomes all subjects completing any of the dose escalation groups were combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation Group 1 | Pro-inflammatory Cytokines | Day 7 value of TNF-alpha | 2.38 pg/mL | Standard Deviation 0.56 |
| Dose Escalation Group 1 | Pro-inflammatory Cytokines | Day 0 value of TNF-alpha | 2.67 pg/mL | Standard Deviation 0.72 |
| Dose Escalation Group 2 | Pro-inflammatory Cytokines | Day 0 value of TNF-alpha | 7.0 pg/mL | Standard Deviation 0 |
| Dose Escalation Group 2 | Pro-inflammatory Cytokines | Day 7 value of TNF-alpha | 7.2 pg/mL | Standard Deviation 0 |