Specialist Dietetic Intervention in Malnourished Patients With Fibrotic

Status Recruiting

Clinical Trial Summary

Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, and pressure ulcers. Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition. Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited. Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD. We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can & should be done. The main aims of this study are: 1. How easy it is to recruit ILD patients to see a dietitian 2. Whether patients will attend dietetic appointments 3. Whether food/nutrient intake is increased following dietetic intervention 4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI & quality of life.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06016959
Study type	Interventional
Source	Royal Brompton & Harefield NHS Foundation Trust
Contact	Rasleen Kahai
Phone	020 7352 8121
Email	r.kahai@rbht.nhs.uk
Status	Recruiting
Phase	N/A
Start date	June 20, 2023
Completion date	March 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Specialist Dietetic Intervention in Malnourished Patients With Fibrotic ILD: a Randomised Controlled Pilot Trial — DT-ILD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms