Environmental Enteropathy Among Infants and Children With Growth Faltering

Ain Shams University

Status: Completed

Conditions: Growth Failure; Enteropathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06497907

FMASU MD 260/2021

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients with growth faltering

Experimental group

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 for 8 weeks and were reassessed.

Treatment:

Dietary Supplement: polymeric formula

Dietary Supplement: peptide based formula