Environmental Enteropathy Among Infants and Children With Growth Faltering

July 5, 2024 updated by: Haya Essam Ibrahim, Ain Shams University

Prevalence of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients with growth faltering received nutritional rehabilitation with polymeric formula and were reassessed after 12 weeks by anthropometric measurements
Dietary supplement: peptide 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks of nutritional rehabilitation with polymeric formula.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks of nutritional rehabilitation with peptide-based formula.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 260/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth Failure

Clinical Trials on polymeric formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe