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CompletedNCT06497907Updated Jul 12, 2024

Environmental Enteropathy Among Infants and Children With Growth Faltering

An interventional study of polymeric formula and peptide based formula in Growth Failure and Enteropathy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Apr 2022, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
6 Months to 5 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Growth Failure
  • Enteropathy
03

In context

Failure to Thrive

84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 56 interventional studies indexed under Failure to Thrive.

Browse Failure to Thrive studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients whose weight below -2 SD for age and sex on the WHO scores.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Patients with growth faltering

    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.

    Dietary Supplement: polymeric formula · Dietary Supplement: peptide based formula

Interventions

  • Dietary supplementpolymeric formula

    Patients with growth faltering received nutritional rehabilitation with polymeric formula and were reassessed after 12 weeks by anthropometric measurements

  • Dietary supplementpeptide based formula

    patients who were defined as non responders and underwent upper gastrointestinal endoscopy and diagnosed as environmental enteropathy, received nutritional rehabilitation with peptide based formula

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 8 weeks of nutritional rehabilitation with peptide-based formula.

07

Study locations

1 site
  • Faculty of Medicine-Ain Shams University
    Cairo, Abbasia 1181, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Jun 2023, 13 months.

Of 18 interventional studies with no phase under Failure to Thrive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2024
First posted
Jul 12, 2024
StartActual
Apr 30, 2022
Primary completionActual
Jun 12, 2023
CompletionActual
Jun 25, 2024
Last update
Jul 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06497907
Responsible party
Haya Essam Ibrahim (Lecturer of pediatrics, Ain Shams University) — Principal investigator
First posted
Jul 12, 2024
Start date
Apr 30, 2022
Primary completion
Jun 12, 2023
Completion
Jun 25, 2024
Last update
Jul 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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