Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

NCT ID: NCT04476056

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2021-11-30

Brief Summary

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Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.

Detailed Description

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Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.

Conditions

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Chronic Pancreatitis Malnutrition Sarcopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Pancreatitis + Malnutrition

Malnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.

Group Type EXPERIMENTAL

Intensified Nutritional Therapy

Intervention Type OTHER

Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.

Interventions

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Intensified Nutritional Therapy

Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)
* Diagnosis of malnutrition

Exclusion Criteria

* Pregnant or breast feeding
* Implanted defibrillator or pacemaker
* History of pancreatic Cancer
* Any other malignant tumor disease within the last 3 years
* Concomitant liver cirrhosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Applied Sciences Neubrandenburg

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. med. Markus M. Lerch

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

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University Medicine Greifswald

Greifswald, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Prof. Dr. med. Markus M. Lerch

Role: CONTACT

+493834867230

Facility Contacts

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Prof. Dr. med. Markus M. Lerch

Role: primary

+493834867230

References

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Wiese ML, Frost F, Meyer F, Muller J, Valentini L, Rischmuller K, Lamprecht G, Steveling A, Lerch MM, Aghdassi AA. An intensified trans-sectoral nutritional intervention in malnourished patients with chronic pancreatitis improves diseases prognosis and identifies potential biomarkers of nutritional status. Front Med (Lausanne). 2024 Oct 8;11:1446699. doi: 10.3389/fmed.2024.1446699. eCollection 2024.

Reference Type DERIVED
PMID: 39440042 (View on PubMed)

Other Identifiers

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BB 069/19

Identifier Type: -

Identifier Source: org_study_id

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