Ulcerative ColitisNCT06824038
Nutritional Counseling Impact on Ulcerative Colitis Patients
A study testing nutritional counseling in people with Ulcerative Colitis, run by Rahma Mohammed Medhat Ali at 1 site in Egypt.
Trial summary
randomized clinical trial aimed to find whether, In ulcerative colitis patients, nutrition counseling is associated with improved nutritional status. objectives: 1. Asses the nutritional status and quality of life among a sample of UC patients attending the NHTMRI outpatient clinic. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 15 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients with moderate Ulcerative Colitis, in active phase.
- Adults aged 18-60, of both sexes
Who cannot join
- Patients with acute fulminant colitis.
- Patient with weight loss > 5% in the last month, and >10% weight loss in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nutrition Counseling on the Nutritional Status of Patients With Ulcerative Colitis: A Randomized Controlled Clinical Trial
randomized clinical trial aimed to find whether, In ulcerative colitis patients, nutrition counseling is associated with improved nutritional status.
objectives:
Read more
- Asses the nutritional status and quality of life among a sample of UC patients attending the NHTMRI outpatient clinic.
- Provide nutritional counseling for the randomly allocated intervention group
- Evaluate the effect of the nutritional counseling on nutritional status, quality of life and disease progression.
- Inclusion criteria: patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes
Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments; while the control arm will receive the regular service at the clinic.
Read the detailed description
Administrative and Preparatory Phase:
After obtaining approval from the corresponding parties, a booklet in Arabic language with educational material and instruction will be prepared. Common foods for and against bowel discomfort will be emphasized. Dietary records will be included to check the adherence of the patients to the instructions.
II- Pre-intervention phase (The initial assessment):
The investigator will review the medical record of each patient to confirm the diagnosis and severity; then eligible patients in both counseling arm and the control arm will be interviewed by the investigator using a structured questionnaire to gather the following data for the initial assessment Personal and socio-demographic data: Comprised enquiry about each patient's age, sex, marital status, occupation, education, residency and telephone/mobile number.
- Assessment of the quality of life using the short inflammatory bowel disease questionnaire (SIBDQ). It is a set of generic, coherent, and easily administered quality of life measures. Scores are from 0 to 10. A higher score indicates better health.
- Assessment of the nutritional status by: i. Weight measurement using the German Beurer Glass Scale model GS11 (with large LCD display (digit zone: 25 mm), loading capacity 150 kg and graduation 100 g ii. Height measurement using the Indian wall mounted DESCO stature meter (Model HSHA 101) with a movable horizontal headboard. Maximal height of measuring is 2 m and measurement resolution of 0.5 cm . iii. Screening all included patients using Nutritional risk screening (NRS 2002). It includes pre-screening with four questions:
- Is the BMI of the patient < 20.5 kg/m2
- Did the patient lose weight in the past 3 months?
- Was the patient's food intake reduced in the past week?
- Is the patient critically ill? If one of these is answered positively, a screening follows which includes surrogate measures of nutritional status, with static and dynamic parameters and data on the severity of the disease (stress metabolism). For each parameter, a score from 0 to 3 can result. Age over 70 years is considered as a risk factor, and is included in the screening tool as well, giving 1 point. A total score of ≥3 points means that the patient is at risk of malnutrition or already malnourished and therefore a nutritional therapy is indicated. iv. Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength, HGS can the incidence of chronic diseases, nutritional status, quality of life, independence of daily life, length of hospital stay, and even mortality v. Skin fold thickness: to measure the double fold of skin and subcutaneous fat to the nearest millimeter. A variety of sites have been used for skinfold measurement, but the most common are triceps, biceps, subscapular and suprailiac. vi. Assessment of nutritional intake using:
- Dietary habits questionnaire: The dietary habits questionnaire included enquiry about the number of meals per day, the main meal, breakfast intake, outdoor fatty meals intake, types of snacks, method of cooking meat, method of cooking vegetables, types of fats used in cooking, sports or physical training, sedentary habits, exposure to sun, dietary supplement intake, dietary habits changes during relapse of the disease (relapse duration in days, the number of meals per day, method of cooking meat, method of cooking vegetables)
- Twenty-four hours dietary recall: The 24-hour dietary recall is an open-ended enquiry about foods consumed during the last 24 hours. It is conducted in an in-depth interview that typically requires 20 to 30 minutes to be completed. Detailed data about food preparation, ingredients in mixed dishes, and the brand name of different commercial products will be collected. Estimation of the amounts of each food consumed in reference to a common size container (e.g., bowls, cups, and glasses), standard measuring cups and spoons. The inevitable limitation is that all information depends on the participants' memory. (Shim et al., 2014) vii) Laboratory assessment: Measurement of Complete blood picture (CBC), and iron.
III- Intervention (Only for the intervention group):
Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Apart from counseling, patients will receive the same care from the clinic medical staff. After the final assessment, the control group will receive the nutritional counseling material to gain its expected benefits.
Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments. The first session for counseling, the second and the third to check the adherence of the patient to the nutrition plan and to answer any question of the patients as follows:
Session 1: Nutritional counseling based on the nutritional assessment of each patient. Each patient will receive a package of:
- A booklet that contains the whole instructions and dietary records to help in remembering information and record their application of the plan. ii. A tailored diet menu adjusted according to the required calories of the patient calculated by the Harris Benedict equation (Habek et al., 2010) considering the patient preferences, individualized requirements and with choices suitable for different economic classes.
Patients will be guided to a diet rich in iron, vitamin D, n-3 fatty acids, and zinc.
Protein requirement are increased in active IBD, and intake should be increased (to 1.2-1.5 g/kg/d in adults) relative to that recommended in the general population.
Probiotic as Lactobacilli can be considered for use in patients with mild to moderate UC for the induction of remission. (Bischoff et al., 2020) A WhatsApp group will be created to add patients at the session 1. Messages will be sent to the patients through the group to stimulate patient adherence to the diet and to remind them of their follow up and final assessment appointments.
Session 2: follow up and reemphasize the instruction. Each patient in the intervention group will receive a weekly telephone follow up session (Tele-health) from a clinical nutritionist to check compliance and respond to inquiries. Between phone sessions, patients can contact their physicians by email or telephone, in addition to the WhatsApp group, or through their routine follow up visits to the IBD clinic to receive their treatment.
I- Post-intervention phase (The final assessment):
All patients in the counseling group and the control groups will be interviewed by the investigator 3 months after the initial assessment session to gather the following data using the same tools of the initial assessment (clinical sheet, follow up laboratory investigations, SIBDQ, NRS 2002, BMI, SFT, HGS, 24 hours dietary recall and dietary habits questionnaire).
- Conditions
- Ulcerative Colitis
- Being tested
- nutritional counseling
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional counselingBehavioural
Nutritional counseling based on the nutritional assessment of each patient. Each patient will receive a package of:
- A booklet that contains the whole instructions and dietary records to help in remembering information and record their application of the plan. ii. A tailored diet menu adjusted according to the required calories of the patient calculated by the Harris Benedict equation, considering the patient preferences, individualized requirements and with choices suitable for different economic classes.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients with moderate Ulcerative Colitis, in active phase, Ages: Adults aged 18-60, of both sexes. Intervention: will receive nutritional counseling sessions ,nd weekly follow-up through clinic vists and mobile phones and messaging Receives: Behavioral: nutritional counseling |
| control group | No intervention | Patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes. will receive regular care of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status
weight in kilograms ,
Measured: three months
nutritional status
body mass index in kg/meter square.
Measured: three months
nutritional status
Nutritional risk screening: The NRS-2002 score is a sum of the total of the nutritional score, severity of disease score and the age adjustment score. The total number of points ranges from 0 to 7. Patients with a score of 3 and more are suggested to have problems with nutrition.
Measured: three months
nutritional status
Hand grip strength measured in kilograms.
Measured: three months
nutritional status
Skin fold thickness in millimeters.
Measured: three months
dietary habits
Dietary habits questionnaire to asses the cooking methods and daily habits.
Measured: three months
dietary habits
Dietary habits questionnaire to asses the cooking methods and daily habits, and, The 24 hour recall to asses food groups intake, macro and micronutrients consumption.
Measured: three months
dietary habits
The 24 hour recall to asses food groups intake, macro and micronutrients consumption.
Measured: three months
quality of life score
asses the QoL through the Short Inflammatory Bowel Disease Questionnaire SIBDQ score. It consists of 10 questions. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor health related quality of life "HRQoL") to 70 (optimal HRQoL).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Sep 2023
- Primary completion31 May 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rahma Mohammed Medhat Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rahma Mohammed Medhat Ali, Cairo University
- Investigators
- Rahma M Ali, Msc, Principal investigator, Faculty of medicine, Port Said UniversityMaha A Al Ghobashy, MD, Study director, Cairo UniversityMarwa R Salem, MD, Study director, Cairo UniversityKamal A El Atrebi, MD, Study chair, National hepatology and tropical medicine research instituteMona Hegazy, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824038
- Sponsor's protocol ID
- MD-53-2023
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dryden GW, Dryden SM. Synergistic Benefits of Dietary Strategies in the Management of IBD. Curr Gastroenterol Rep. 2025 Dec;27(1):8. doi: 10.1007/s11894-024-00949-1. Epub 2024 Dec 19.
PubMed 39702516Jaramillo AP, Abaza A, Sid Idris F, Anis H, Vahora I, Moparthi KP, Al Rushaidi MT, Muddam M, Obajeun OA. Diet as an Optional Treatment in Adults With Inflammatory Bowel Disease: A Systematic Review of the Literature. Cureus. 2023 Jul 18;15(7):e42057. doi: 10.7759/cureus.42057. eCollection 2023 Jul.
PubMed 37601990
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutrition Counseling on the Nutritional Status of Patients With Ulcerative Colitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06824038
- Acronym / sponsor ID
- MD-53-2023
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Rahma Mohammed Medhat AliUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 13 Feb 2025 (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.
randomized clinical trial aimed to find whether, In ulcerative colitis patients, nutrition counseling is associated with improved nutritional status.
objectives:
- Asses the nutritional status and quality of life among a sample of UC patients attending the NHTMRI outpatient clinic.
- Provide nutritional counseling for the randomly allocated intervention group
- Evaluate the effect of the nutritional counseling on nutritional status, quality of life and disease progression.
- Inclusion criteria: patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes
Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments; while the control arm will receive the regular service at the clinic.
Detailed description
Administrative and Preparatory Phase:
After obtaining approval from the corresponding parties, a booklet in Arabic language with educational material and instruction will be prepared. Common foods for and against bowel discomfort will be emphasized. Dietary records will be included to check the adherence of the patients to the instructions.
II- Pre-intervention phase (The initial assessment):
The investigator will review the medical record of each patient to confirm the diagnosis and severity; then eligible patients in both counseling arm and the control arm will be interviewed by the investigator using a structured questionnaire to gather the following data for the initial assessment Personal and socio-demographic data: Comprised enquiry about each patient's age, sex, marital status, occupation, education, residency and telephone/mobile number.
- Assessment of the quality of life using the short inflammatory bowel disease questionnaire (SIBDQ). It is a set of generic, coherent, and easily administered quality of life measures. Scores are from 0 to 10. A higher score indicates better health.
- Assessment of the nutritional status by: i. Weight measurement using the German Beurer Glass Scale model GS11 (with large LCD display (digit zone: 25 mm), loading capacity 150 kg and graduation 100 g ii. Height measurement using the Indian wall mounted DESCO stature meter (Model HSHA 101) with a movable horizontal headboard. Maximal height of measuring is 2 m and measurement resolution of 0.5 cm . iii. Screening all included patients using Nutritional risk screening (NRS 2002). It includes pre-screening with four questions:
- Is the BMI of the patient < 20.5 kg/m2
- Did the patient lose weight in the past 3 months?
- Was the patient's food intake reduced in the past week?
- Is the patient critically ill? If one of these is answered positively, a screening follows which includes surrogate measures of nutritional status, with static and dynamic parameters and data on the severity of the disease (stress metabolism). For each parameter, a score from 0 to 3 can result. Age over 70 years is considered as a risk factor, and is included in the screening tool as well, giving 1 point. A total score of ≥3 points means that the patient is at risk of malnutrition or already malnourished and therefore a nutritional therapy is indicated. iv. Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength, HGS can the incidence of chronic diseases, nutritional status, quality of life, independence of daily life, length of hospital stay, and even mortality v. Skin fold thickness: to measure the double fold of skin and subcutaneous fat to the nearest millimeter. A variety of sites have been used for skinfold measurement, but the most common are triceps, biceps, subscapular and suprailiac. vi. Assessment of nutritional intake using:
- Dietary habits questionnaire: The dietary habits questionnaire included enquiry about the number of meals per day, the main meal, breakfast intake, outdoor fatty meals intake, types of snacks, method of cooking meat, method of cooking vegetables, types of fats used in cooking, sports or physical training, sedentary habits, exposure to sun, dietary supplement intake, dietary habits changes during relapse of the disease (relapse duration in days, the number of meals per day, method of cooking meat, method of cooking vegetables)
- Twenty-four hours dietary recall: The 24-hour dietary recall is an open-ended enquiry about foods consumed during the last 24 hours. It is conducted in an in-depth interview that typically requires 20 to 30 minutes to be completed. Detailed data about food preparation, ingredients in mixed dishes, and the brand name of different commercial products will be collected. Estimation of the amounts of each food consumed in reference to a common size container (e.g., bowls, cups, and glasses), standard measuring cups and spoons. The inevitable limitation is that all information depends on the participants' memory. (Shim et al., 2014) vii) Laboratory assessment: Measurement of Complete blood picture (CBC), and iron.
III- Intervention (Only for the intervention group):
Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Apart from counseling, patients will receive the same care from the clinic medical staff. After the final assessment, the control group will receive the nutritional counseling material to gain its expected benefits.
Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments. The first session for counseling, the second and the third to check the adherence of the patient to the nutrition plan and to answer any question of the patients as follows:
Session 1: Nutritional counseling based on the nutritional assessment of each patient. Each patient will receive a package of:
- A booklet that contains the whole instructions and dietary records to help in remembering information and record their application of the plan. ii. A tailored diet menu adjusted according to the required calories of the patient calculated by the Harris Benedict equation (Habek et al., 2010) considering the patient preferences, individualized requirements and with choices suitable for different economic classes.
Patients will be guided to a diet rich in iron, vitamin D, n-3 fatty acids, and zinc.
Protein requirement are increased in active IBD, and intake should be increased (to 1.2-1.5 g/kg/d in adults) relative to that recommended in the general population.
Probiotic as Lactobacilli can be considered for use in patients with mild to moderate UC for the induction of remission. (Bischoff et al., 2020) A WhatsApp group will be created to add patients at the session 1. Messages will be sent to the patients through the group to stimulate patient adherence to the diet and to remind them of their follow up and final assessment appointments.
Session 2: follow up and reemphasize the instruction. Each patient in the intervention group will receive a weekly telephone follow up session (Tele-health) from a clinical nutritionist to check compliance and respond to inquiries. Between phone sessions, patients can contact their physicians by email or telephone, in addition to the WhatsApp group, or through their routine follow up visits to the IBD clinic to receive their treatment.
I- Post-intervention phase (The final assessment):
All patients in the counseling group and the control groups will be interviewed by the investigator 3 months after the initial assessment session to gather the following data using the same tools of the initial assessment (clinical sheet, follow up laboratory investigations, SIBDQ, NRS 2002, BMI, SFT, HGS, 24 hours dietary recall and dietary habits questionnaire).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: nutritional counselingPatients with moderate Ulcerative Colitis, in active phase, Ages: Adults aged 18-60, of both sexes. Intervention: will receive nutritional counseling sessions ,nd weekly follow-up through clinic vists and mobile phones and messaging |
| control group | No intervention | –Patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes. will receive regular care of the clinic. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with moderate Ulcerative Colitis, in active phase.
- Adults aged 18-60, of both sexes
Key exclusion criteria (2 listed)
- Patients with acute fulminant colitis.
- Patient with weight loss > 5% in the last month, and >10% weight loss in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional counselingNutritional counseling based on the nutritional assessment of each patient. Each patient will receive a package of: i. A booklet that contains the whole instructions and dietary records to help in remembering information and record their application of the plan. ii. A tailored diet menu adjusted according to the required calories of the patient calculated by the Harris Benedict equation, considering the patient preferences, individualized requirements and with choices suitable for different economic classes. | Behavioural | intervention group |
Primary outcome
nutritional status
Time frame: three months
weight in kilograms ,
nutritional status
Time frame: three months
body mass index in kg/meter square.
nutritional status
Time frame: three months
Nutritional risk screening: The NRS-2002 score is a sum of the total of the nutritional score, severity of disease score and the age adjustment score. The total number of points ranges from 0 to 7. Patients with a score of 3 and more are suggested to have problems with nutrition.
nutritional status
Time frame: three months
Hand grip strength measured in kilograms.
nutritional status
Time frame: three months
Skin fold thickness in millimeters.
dietary habits
Time frame: three months
Dietary habits questionnaire to asses the cooking methods and daily habits.
dietary habits
Time frame: three months
Dietary habits questionnaire to asses the cooking methods and daily habits, and, The 24 hour recall to asses food groups intake, macro and micronutrients consumption.
dietary habits
Time frame: three months
The 24 hour recall to asses food groups intake, macro and micronutrients consumption.
quality of life score
Time frame: three months
asses the QoL through the Short Inflammatory Bowel Disease Questionnaire SIBDQ score. It consists of 10 questions. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor health related quality of life "HRQoL") to 70 (optimal HRQoL).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 39702516Dryden GW, Dryden SM. Synergistic Benefits of Dietary Strategies in the Management of IBD. Curr Gastroenterol Rep. 2025 Dec;27(1):8. doi: 10.1007/s11894-024-00949-1. Epub 2024 Dec 19.
- Background: PubMed 37601990Jaramillo AP, Abaza A, Sid Idris F, Anis H, Vahora I, Moparthi KP, Al Rushaidi MT, Muddam M, Obajeun OA. Diet as an Optional Treatment in Adults With Inflammatory Bowel Disease: A Systematic Review of the Literature. Cureus. 2023 Jul 18;15(7):e42057. doi: 10.7759/cureus.42057. eCollection 2023 Jul.
- Individual participant dataSharing planned: No
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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.
Rahma M Ali, Msc principal investigator
Faculty of medicine, Port Said University
Maha A Al Ghobashy, MD study director
Cairo University
Marwa R Salem, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional counseling in people with Ulcerative Colitis, run by Rahma Mohammed Medhat Ali at 1 site in Egypt.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional status (time frame: three months). The study lists 9 primary outcomes in all. 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 NCT06824038, which also lists 2 linked publications.
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 13 Feb 2025.