NCT04476056

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

June 29, 2020

Last Update Submit

July 13, 2020

Conditions

Chronic PancreatitisMalnutritionSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria

    Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months

    6 months

Secondary Outcomes (72)

  • Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria

    28 days, 3 months, 6 months

  • Dropout Rate

    28 days, 3 months, 6 months

  • Compliance to Oral Nutritional Supplements

    28 days, 3 months, 6 months

  • Compliance to Dietary Counselling

    28 days, 3 months, 6 months

  • Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria

    28 days, 3 months, 6 months

  • +67 more secondary outcomes

Study Arms (1)

Chronic Pancreatitis + Malnutrition

EXPERIMENTAL

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

Other: Intensified Nutritional Therapy

Interventions

Intensified Nutritional TherapyOTHER

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.

Chronic Pancreatitis + Malnutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39440042DERIVED

MeSH Terms

Conditions

Pancreatitis, ChronicMalnutritionSarcopenia

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Prof. Dr. med. Markus M. Lerch

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. med. Markus M. Lerch

CONTACT

+493834867230markus.lerch@med.uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 17, 2020

Study Start

May 28, 2019

Primary Completion

May 30, 2021

Study Completion

November 30, 2021

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

DE(1)