Page Title
Clinical Trial Finder
Nutritional-GI Enrolling
Study of new enzyme therapy NHS7108 in Adults With Exocrine Pancreatic Insufficiency (Nestle 2307CLI)
This study will assess the safety and effectiveness of NHS7108 to see how it works compared to the approved pancreatic enzyme replacement therapy, Zenpep in adults with pancreatic insufficiency.
All participants in the study will stop taking their usual enzyme treatment for up to 8 days. Then everyone in the study will take NHS71018 for about two weeks before switching to Zenpep for another two weeks. Both treatments are capsules that are taken with meals and snacks each day.
Participants will stay at the study site for three week-long periods to allow for a special diet, stool collection, and blood testing. The total study duration is about 14 weeks.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 85 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will have exocrine pancreatic insufficiency (EPI) and must be taking pancreatic enzymes.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
10 weeks -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Nestle Health Science -
Study Drugs:
Study Sites
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Enrolling Soon
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
Contact
Lynn Fukushima
Phone: +1 (323) 442-8522
Email: lynn.fukushima@med.usc.edu
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Enrolling Soon
Maine
Maine Medical Center, Portland, ME 04102
Contact
Harmony Renna
Phone: +1 (207) 662-5917
Email: Harmony.Renna@mainehealth.org
-
Enrolling Soon
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Jeanne Pinto
Phone: +1 (410) 955-9782
Email: jpinto4@jh.edu
-
Enrolling Soon
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
Enrolling Soon
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 85 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will have exocrine pancreatic insufficiency (EPI) and must be taking pancreatic enzymes.
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