Growth FailureNCT06497907
Environmental Enteropathy Among Infants and Children With Growth Faltering
A study testing polymeric formula and peptide based formula in people with Growth Failure and Enteropathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Growth Failure, Enteropathy
- What is being tested?
- polymeric formula and peptide based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 25 Jun 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients whose weight below -2 SD for age and sex on the WHO scores.
Who cannot join
- Secondary cases of malnutrition or undernutrition.
- Patients with symptoms of GIT problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum.
- Patients who can't commit to a follow up visit every two weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Environmental Enteropathy Among Infants and Children With Growth Faltering
The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.
- Conditions
- Growth Failure, Enteropathy
- Being tested
- polymeric formula, peptide based formula
- Medical subject headings
- Failure to Thrive, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymeric formulaDietary supplement
Patients with growth faltering received nutritional rehabilitation with polymeric formula and were reassessed after 12 weeks by anthropometric measurements
peptide based formulaDietary supplement
patients who were defined as non responders and underwent upper gastrointestinal endoscopy and diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula
| Study group | Role | What they receive |
|---|---|---|
| Patients with growth faltering | Experimental | Patient with growth faltering whose weight still below -2 SD for age and sex on the WHO scores after 12 weeks of nutritional rehabilitation with polymeric formula, underwent upper gastrointestinal endoscopy and who were diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula for 8 weeks and were reassessed. Receives: Dietary Supplement: polymeric formula; Dietary Supplement: peptide based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of environmental enteropathy among children with faltering growth.
Assess the number of patients whose weight still below -2SD and upper gastrointestinal endoscopy showed the criteria of environmental enteropathy.
Measured: 12 weeks of nutritional rehabilitation with polymeric formula.
Secondary outcomes (1)
Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula.
Weight z- score
Measured: 8 weeks of nutritional rehabilitation with peptide-based formula.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start30 Apr 2022
- Primary completion12 Jun 2023
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient with growth faltering whose weight still below -2 SD for age and sex on the WHO scores after 12 weeks of nutritional rehabilitation with polymeric formula, underwent upper gastrointestinal endoscopy and who were diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula and probiotics
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Essam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497907
- Sponsor's protocol ID
- FMASU MD 260/2021
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Environmental Enteropathy Among Infants and Children With Growth Faltering
- ClinicalTrials.gov ID
- NCT06497907
- Acronym / sponsor ID
- FMASU MD 260/2021
- Conditions
- Growth Failure, Enteropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 12 Jul 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.
The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient with growth faltering whose weight still below -2 SD for age and sex on the WHO scores after 12 weeks of nutritional rehabilitation with polymeric formula, underwent upper gastrointestinal endoscopy and who were diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula and probiotics
| Arm | Type | Receives |
|---|---|---|
| Patients with growth faltering | Experimental | Dietary Supplement: polymeric formula, Dietary Supplement: peptide based formulaPatient with growth faltering whose weight still below -2 SD for age and sex on the WHO scores after 12 weeks of nutritional rehabilitation with polymeric formula, underwent upper gastrointestinal endoscopy and who were diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula for 8 weeks and were reassessed. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients whose weight below -2 SD for age and sex on the WHO scores.
Key exclusion criteria (3 listed)
- Secondary cases of malnutrition or undernutrition.
- Patients with symptoms of GIT problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum.
- Patients who can't commit to a follow up visit every two weeks.
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 |
|---|---|---|
| polymeric formulaPatients with growth faltering received nutritional rehabilitation with polymeric formula and were reassessed after 12 weeks by anthropometric measurements | Dietary supplement | Patients with growth faltering |
| peptide based formulapatients who were defined as non responders and underwent upper gastrointestinal endoscopy and diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula | Dietary supplement | Patients with growth faltering |
Primary outcome
Assessment of the prevalence of environmental enteropathy among children with faltering growth.
Time frame: 12 weeks of nutritional rehabilitation with polymeric formula.
Assess the number of patients whose weight still below -2SD and upper gastrointestinal endoscopy showed the criteria of environmental enteropathy.
1 secondary outcome
Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula.
Time frame: 8 weeks of nutritional rehabilitation with peptide-based formula.
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polymeric formula and peptide based formula in people with Growth Failure and Enteropathy, run by Ain Shams University 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 1 inclusion and 3 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 12 Jul 2024. 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?
Assessment of the prevalence of environmental enteropathy among children with faltering growth. (time frame: 12 weeks of nutritional rehabilitation with polymeric formula.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.