Environmental Enteropathy Among Infants and Children With Growth Faltering

NCT06497907 | Completed

• 1 other identifier: FMASU MD 260/2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Failure; Enteropathy

Outcome Measures

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.

  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.

  8 weeks of nutritional rehabilitation with peptide-based formula.

Study Arms (1)

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.

Dietary Supplement: polymeric formula; Dietary Supplement: peptide based formula

Interventions

polymeric formula DIETARY_SUPPLEMENT

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

Patients with growth faltering

peptide based formula DIETARY_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

Patients with growth faltering

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Location

MeSH Terms

Conditions

Failure to Thrive; Intestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatrics

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 12, 2024
• Study Start: April 30, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 25, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

EG (1)