NCT07496801

Brief Summary

Intestinal parasitic infections (IPIs) are highly prevalent worldwide, particularly among children living in lowresource settings. (1) These infections pose a significant public health challenge due to their widespread distribution and their impact on vulnerable populations, especially preschool and school-aged children. (2) Common intestinal parasites include protozoa such as Giardia lamblia and Entamoeba histolytica, as well as helminths like Ascaris lumbricoides, Trichuris trichiura, and hookworms.(3) IPIs contribute to a range of health problems in children, including diarrhea, anemia, general weakness, and impaired physical development. These infections often cause malabsorption of nutrients and chronic blood loss, which can severely affect children's growth and overall health status. (2) Malnutrition has been defined by the World Health Organization as a major global health challenge with significant implications for morbidity and mortality worldwide.(4) It is characterized by conditions such as stunting, wasting, and underweight, all of which reflect inadequate nutrition and impaired growth. . (Yoseph \& Beyene, 2020).Malnutrition is influenced by multiple interconnected factors including socioeconomic status, inadequate feeding practices, lack of exclusive breastfeeding, recurrent infections, limited healthcare access, and poor environmental conditions such as unsafe water and sanitation. (5) Persistent and/or recurring IPIs are considered important contributors to adverse developmental outcomes depending on parasite species and infection dynamics.(6) They may contribute to malnutrition through both direct and indirect mechanisms. Directly, they can induce chronic subclinical systemic inflammation and modulate the host immune response to ensure persistence, resulting in adverse effects on growth.(7) For example, infection with Cryptosporidium spp. has been linked to reduced length-for-age, mediated by increased systemic inflammation and decreased circulating IGF-1 concentrations.(8) Indirectly, they may promote environmental enteric dysfunction (EED), which is subclinical disorder of the small intestine that can contribute to malnutrition. It involves villous atrophy and crypt hyperplasia, reducing nutrient absorption, and infections such as G. lamblia may play a key role in its development.(6) Additionally IPIs may interact with the normal gut microbiota, with each influencing the other's pathogenic potential, and this interaction can contribute to malnutrition.(7) IPIs can reduce food intake by causing illness, abdominal discomfort, or altering appetite regulation.(8) They may affect neuroendocrine signals, modifying taste perception and satiety hormones, such as elevated leptin levels observed in children infected with E. histolytica, Strongyloides spp., and G. lamblia. Infections like Trichuris trichiura have also been linked to lower intake of protein, energy, iron and riboflavin.(6) While parasites like hookworm directly cause nutrient loss through blood and iron depletion, often resulting in anaemia. (1) Deficiencies in zinc, vitamin D and omega-3 fatty acids are common in children affected by malnutrition and parasitic infections. Zinc and vitamin D is essential for gut integrity, immune function, and growth, while omega-3 fatty acids support intestinal structure and have anti-inflammatory effects. Low levels of these nutrients may worsen intestinal dysfunction, including EED, and contribute to impaired growth.(9) In the light of the previously discussed mechanisms, a strong bidirectional relationship exists between parasitic infections and malnutrition, whereby each condition aggravates the other, forming a vicious cycle that increases the risk of stunting, poor growth, anaemia, and impaired immune function.(3)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • the prevelance of intestinal parasitic infections

    Determine the prevelance of intestinal parasitic infections in different forms of undernutrition children compared with normal controls.

    baseline

Study Arms (2)

Group A

patients with different forms of undernutrition

control group

normal child

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Malnourished children identified based on anthropometric measurements according to the growth standards of the World Health Organization. Height-for-Age, Weight-for-Age and Weight-for-Height were \<-2 standard deviation (SD) were classified as stunted, wasted, and underweight, respectively.

You may qualify if:

  • Children aged 2-15 years of both sexes.
  • Children whose parents provide informed written consent.
  • Malnourished children identified based on anthropometric measurements according to the growth standards of the World Health Organization. Height-for-Age, Weight-for-Age and Weight-for-Height were \<-2 standard deviation (SD) were classified as stunted, wasted, and underweight, respectively.
  • Apparently healthy control children of similar age groups

You may not qualify if:

  • Children with chronic systemic diseases (e.g., chronic renal, hepatic, cardiac, or endocrine disorders).
  • Children with known genetic or congenital disorders affecting growth.
  • Children who received micronutrient supplementation (omega 3, zinc, vitamin D) within the last 3 months.
  • Children who received antiparasitic treatment within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03