Chronic PancreatitisNCT02577640
Dietary Soy Isoflavones In Chronic Pancreatitis
A study testing Soy bread in people with Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
Trial summary
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Soy bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Soy bread
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy breadDietary supplement
Also called Soy Isoflavones
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (DE) Phase | Experimental | Here a traditional 3+3 design will be used to determine the compliance, tolerability and dose limiting toxicities in this unique patient population. Dose escalation with soy bread will be continued until dose-limiting toxicities are observed in >33% of the participants or the daily target dose of 4 slices of bread [132 mg soy isoflavone] is reached. Receives: Dietary Supplement: Soy bread |
| Maximum Tolerated Dose (MTD) Phase | Experimental | After the Phase I study has been completed, an additional 10 chronic pancreatitis patients will be treated at the best tolerated dose of soy bread for 4 weeks to further verify safety and toxicity. Receives: Dietary Supplement: Soy bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 (dose escalation groups) or 4 (maximally tolerated dose) weeks
Secondary outcomes (1)
Pro-inflammatory Cytokines
Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread
Measured: 1 (dose escalation group) or 4 weeks (maximally tolerated subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Hart, Ohio State University
- Investigators
- Philip Hart, MD, Principal investigator, The Ohio State Wexner Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577640
- Sponsor's protocol ID
- 2014H0226
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2015
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahn-Jarvis J, Lombardo E, Cruz-Monserrate Z, Badi N, Crowe O, Kaul S, Komar H, Krishna SG, Lesinski GB, Mace TA, Ramsey ML, Roberts K, Stinehart K, Traczek M, Conwell DL, Vodovotz Y, Hart PA. Reduction of inflammation in chronic pancreatitis using a soy bread intervention: A feasibility study. Pancreatology. 2020 Jul;20(5):852-859. doi: 10.1016/j.pan.2020.04.018. Epub 2020 Jun 6.
PubMed 32595109
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Soy Isoflavones In Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02577640
- Acronym / sponsor ID
- 2014H0226
- Conditions
- Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 12 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (DE) Phase | Experimental | Dietary Supplement: Soy breadHere a traditional 3+3 design will be used to determine the compliance, tolerability and dose limiting toxicities in this unique patient population. Dose escalation with soy bread will be continued until dose-limiting toxicities are observed in >33% of the participants or the daily target dose of 4 slices of bread [132 mg soy isoflavone] is reached. |
| Maximum Tolerated Dose (MTD) Phase | Experimental | Dietary Supplement: Soy breadAfter the Phase I study has been completed, an additional 10 chronic pancreatitis patients will be treated at the best tolerated dose of soy bread for 4 weeks to further verify safety and toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios:
- Age ≥18 years
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy breadAlso: Soy IsoflavonesSoy 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. | Dietary supplement | Dose Escalation (DE) Phase, Maximum Tolerated Dose (MTD) Phase |
Primary outcome
Dose Limiting Toxicities
Time frame: 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.
1 secondary outcome
Pro-inflammatory Cytokines
Time frame: 1 (dose escalation group) or 4 weeks (maximally tolerated subject)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32595109Ahn-Jarvis J, Lombardo E, Cruz-Monserrate Z, Badi N, Crowe O, Kaul S, Komar H, Krishna SG, Lesinski GB, Mace TA, Ramsey ML, Roberts K, Stinehart K, Traczek M, Conwell DL, Vodovotz Y, Hart PA. Reduction of inflammation in chronic pancreatitis using a soy bread intervention: A feasibility study. Pancreatology. 2020 Jul;20(5):852-859. doi: 10.1016/j.pan.2020.04.018. Epub 2020 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Hart, MD principal investigator
The Ohio State Wexner Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy bread in people with Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: 1 (dose escalation groups) or 4 (maximally tolerated dose) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.