NCT06704607

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 27, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

November 26, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 27, 2024

Last Update Submit

November 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asses The Change In Quality of life

    measured by the St. George's Respiratory Questionnaire (SGRQ).

    base line

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • \*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.

You may not qualify if:

  • \*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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Martinez Garcia MA, Maiz Carro L, Catalan Serra P. [Treatment of non-cystic fibrosis bronchiectasis]. Arch Bronconeumol. 2011 Dec;47(12):599-609. doi: 10.1016/j.arbres.2011.06.003. Epub 2011 Jul 28. Spanish.

    PMID: 21798654BACKGROUND

Central Study Contacts

Hend Mohamed Sayed, Doctor

CONTACT

Ahmed mohamed Shadad, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of chest disease at assiut university

Study Record Dates

First Submitted

October 27, 2024

First Posted

November 26, 2024

Study Start

November 20, 2024

Primary Completion

February 20, 2025

Study Completion

March 20, 2025

Last Updated

November 26, 2024

Record last verified: 2024-10