Environmental Enteropathy Among Infants and Children With Growth Faltering

NCT ID: NCT06497907

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2024-06-25

Brief Summary

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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

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Conditions

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Growth Failure Enteropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

polymeric formula

Intervention Type DIETARY_SUPPLEMENT

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

peptide based formula

Intervention Type 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

Interventions

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polymeric formula

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Haya Essam Ibrahim

Lecturer of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine-Ain Shams University

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MD 260/2021

Identifier Type: -

Identifier Source: org_study_id

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