Environmental Enteropathy Among Infants and Children With Growth Faltering

Not Applicable

Completed

• Conditions: Enteropathy; Growth Failure
• Interventions: Dietary Supplement: polymeric formula; Dietary Supplement: peptide based formula

• Registration Number: NCT06497907
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-30
• Primary Completion: 2023-06-12
• Study Completion: 2024-06-25
• Study First Submitted: 2024-06-25
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with growth faltering	polymeric formula	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.
Patients with growth faltering	peptide based formula	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.

Primary Outcome Measures

Name	Time	Method
Assessment of the prevalence of environmental enteropathy among children with faltering growth.	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.

Secondary Outcome Measures

Name	Time	Method
Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula.	8 weeks of nutritional rehabilitation with peptide-based formula.	Weight z- score

Trial Locations

Locations (1)

Faculty of Medicine-Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt