Optimization of Nutritional State on the Outcome of Patients with Acute Exacerbation of Bronchiectasis

November 25, 2024 updated by: Hend Mohamed Sayed Mohamed, Assiut University

Impact of Optimization of Nutritional State on the Outcome of Patients with Acute Exacerbation of Bronchiectasis

Bronchiectasis is a chronic respiratory condition characterized by the abnormal and permanent dilation of the bronchi, leading to recurrent respiratory infections, chronic cough, and significant morbidity. The disease has gained increasing recognition due to its rising prevalence and the substantial burden it places on healthcare systems .

Recent studies have highlighted the importance of nutritional status in managing chronic respiratory diseases, including bronchiectasis. Malnutrition is prevalent among patients with bronchiectasis, particularly those experiencing frequent exacerbations. It has been shown that underweight patients have lower lung function and may face worse clinical outcomes compared to those with normal weight . Specifically, a study found that underweight individuals had a significantly lower forced expiratory volume in one second (FEV1) compared to their normal-weight counterparts, indicating a direct correlation between nutritional status and respiratory function .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

To evaluate the effects of nutritional optimization on clinical outcomes in patients experiencing an acute exacerbation of bronchiectasis. Specifically, the study seeks to:

  • Assess the Relationship Between Nutritional Status and Clinical Outcomes*: To investigate how improvements in nutritional status, measured through dietary intake, body weight, and biochemical markers, correlate with clinical outcomes such as length of hospital stay, frequency of exacerbations, and overall recovery.

    • *Evaluate the Effectiveness of Nutritional Interventions*: To determine the impact of specific nutritional interventions (e.g., high-protein diets, caloric supplementation, and micronutrient support) on the health status and recovery of patients during acute exacerbations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Recruitment Patients will be recruited from inpatient wards. Informed consent will be obtained from all participants prior to enrollment.

Nutritional Assessment

  • **Baseline Assessment**:
  • Nutritional status will be determined using the Subjective Global Assessment (SGA) and biochemical markers (e.g., serum albumin).
  • Dietary intake will be assessed using a 3-day food diary or 24-hour dietary recall method.
  • **Nutritional Optimization**: Patients identified as malnourished will receive a tailored nutritional intervention, which may include:
  • High-protein dietary recommendations.
  • Caloric supplementation through protein shakes or high-calorie snacks.
  • Micronutrient supplementation as need

Data Collection

Data will be collected at three time points:

  1. **Baseline**: Upon admission.
  2. **During Hospitalization**: After the implementation of nutritional interventions.
  3. **Follow-Up**: Six months post-discharge, assessing long-term outcomes.

Description

Inclusion Criteria:

  • *Age*: Adults aged 18 years and older.

    • Diagnosis*: Confirmed diagnosis of bronchiectasis, as established by clinical evaluation and imaging studies (e.g., chest CT scan).
    • Acute Exacerbation*: Patients presenting with acute exacerbation symptoms, such as increased sputum production, worsening dyspnea, or chest pain.
    • Nutritional Assessment*: Patients identified as malnourished or at risk of malnutrition based on the Subjective Global Assessment (SGA) or similar nutritional screening tools.

Exclusion Criteria:

  • *Cognitive Impairment*: Patients with cognitive impairments that affect their ability to participate in the study or adhere to nutritional recommendations.

    • Current Enteral Feeding*: Patients receiving enteral nutrition or those with a feeding tube.

Recent Nutritional Interventions*: Patients who have recently undergone significant nutritional interventions (e.g., dietary changes, supplementation) within the past three months prior to enrollment.

*Pregnancy or Lactation*: Pregnant or lactating women, due to the need for specific nutritional considerations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asses The Change In Quality of life
Time Frame: base line
measured by the St. George's Respiratory Questionnaire (SGRQ).
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bronchiectas nutritional state

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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