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Completed

NCT Number: NCT06497907

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.

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Key information

Conditions

Growth Failure Digestive System Diseases Enteropathy Failure to Thrive Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polymeric formula

Dietary Supplement

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Weight z- score

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Prevalence of Environmental Enteropathy Among Infants and Children With Growth Faltering

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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