Bronchiectasis AdultNCT06704607
Optimization of Nutritional State on the Outcome of Patients With Acute Exacerbation of Bronchiectasis
An observational study of Bronchiectasis Adult, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 20 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- *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.
Who cannot join
- *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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Bronchiectasis Adult
What is being measured
The primary outcome is the main question the study is designed to answer.
Asses The Change In Quality of life
measured by the St. George's Respiratory Questionnaire (SGRQ).
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704607
- Sponsor's protocol ID
- Bronchiectas nutritional state
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21798654
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optimization of Nutritional State on the Outcome of Patients With Acute Exacerbation of Bronchiectasis
- ClinicalTrials.gov ID
- NCT06704607
- Acronym / sponsor ID
- Bronchiectas nutritional state
- Conditions
- Bronchiectasis Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- *Age*: Adults aged 18 years and older.
Key exclusion criteria (4 listed)
- *Cognitive Impairment*: Patients with cognitive impairments that affect their ability to participate in the study or adhere to nutritional recommendations.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asses The Change In Quality of life
Time frame: base line
measured by the St. George's Respiratory Questionnaire (SGRQ).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Results publication: PubMed 21798654Martinez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend Mohamed Sayed, Doctor (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses The Change In Quality of life (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.