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Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children

The Application of Potential Biotechnologies to Develop Novel Probiotics Functional Food Products With High Viability for Modulating the Gut Microbiome Among Healthy and Under Stress Subiects

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06561724
Enrollment
72
Registered
2024-08-20
Start date
2023-06-01
Completion date
2025-03-01
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Microbial Colonization

Keywords

Gut microbiome, Diarrhea, Irritable bowel syndrome, Inulin prebiotic, Metagenomic analysis, Fecal Secretory immunoglobulin A, Fecal short chain fatty acids

Brief summary

The study described herein seeks to assess the extent to which diet supplementation of young Egyptian children, one of the most vulnerable groups to the risk of diarrhea, with prebiotic fiber can improve their gut health.

Detailed description

The gastrointestinal tract (GI) is an indispensable organ for any human. In addition to digesting and extracting nutrients from consumed foods, it also houses the largest community of human-associated microbes (called human gut microbiota), plays a role in immune system development and modulation, participates in water and electrolyte balancing, and excretes waste products. Because the human gut is constantly affected by external stimuli and foreign objects via food ingestion, it is not surprising that GI tract diseases, and especially diarrheal disease, are one of the most common causes of human illness. Diarrhea is especially prevalent at younger age, and indeed many young Egyptian children are vulnerable to develop such illness. Healthy GI tract is the most densely populated human-associated microbial habitat and harbors a highly diverse microbial community. This gut microbiota functions as an essential organ in nutrition, immunity, and physiology of human hosts. Gut microbes are responsible for polysaccharide hydrolysis, vitamin production, immune system stimulation, and modulation of gut motility. While healthy gut microbiome provides protection of the human host against pathogen invasion, microbiota disbalance opens doors for the host to be colonized by intestinal pathogens including viruses, virulent bacteria, and parasites, which all can cause diarrhea. The burden of gut infections is high in Egypt, especially among young children. The vulnerability of these groups to gut infections has been linked previously to the level of hygiene and the integrity of intestinal barrier function, and can also be associated with the prevalence of pathogenic microbes in consumed foods such as poultry. The consumption of contaminated food and water, poor health knowledge, and ineffective infection control programs are contributing considerably to the persistence of enteric infections. One of the approaches to reduce the prevalence of intestinal infections and resulting diarrhea is to improve overall gut health, by promoting the development of healthy gut microbiota and strengthening gut barrier function. Many dietary components can affect the composition and function of human gut microbiome. Among these, dietary fiber constitutes a variety of polysaccharides that are largely undigested and unabsorbed by humans (who lack enzymes required to break them), but are readily degraded by microbes in the large bowel. Fiber species that are selectively utilized by microbes and provide health benefits to the host are called prebiotics. These prebiotic fibers, such as inulin, selectively promote growth and expansion of beneficial members of our gut community, thus making it harder for pathogens to establish themselves in the gut. Fiber degradation by resident gut microbes also increases the levels of beneficial short chain fatty acids (SCFAs), which were shown to improve gut barrier function and reduce tissue inflammation.

Interventions

DIETARY_SUPPLEMENTBiscuits maltodextrin

Biscuits includes maltodextrin

DIETARY_SUPPLEMENTBiscuits includes prebiotics tartoufa inulin

Biscuits prebiotics

DIETARY_SUPPLEMENTBiscuits includes prebiotics chicory inulin

Biscuits prebiotics

Sponsors

Wright State University
CollaboratorOTHER
National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Randomized blind parallel three -arm randomized controlled trial (RCT). The RCT is double-blind, in which both the nutritionist and the volunteers are blinded to the actual biscuit allocated to the volunteer; i.e., neither the nutritionist in charge of distributing the biscuit nor the volunteer knows whether the volunteer has received prebiotic rich biscuit or placebo.

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

• The inclusion criteria were children aged ≥3 and below 6 years and the ability of the child's mother to comply with the research protocol and to collect the biological materials at predetermined dates.

Exclusion criteria

* gastrointestinal diseases * chronic diseases (such as type 1 diabetes) * intake of antibiotics within the previous 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Fecal secretory immune globulin A (sIgA)2 monthsFecal secretory s-IGA was assayed by the Chrom ELISA kit (Bio Vender research Diagnostics, Cat # RIC6100, Germany) and the instruction of the manufacturer was followed. Aliquots (80-120 mg) of the thawed fecal samples collected above at baseline and at the termination of the trial were suspended in 10-fold exes (15 m) shitoog a phspaste burier protered and entrifuged at 3o0 omn for s min. Tipes were simultaneously run in the ELISA and the concentration of s-IgA was read at 405 mm in ELISA reader against a standard curve and the results were expressed as mg faecal S-IgA per 100 gram stool.

Secondary

MeasureTime frameDescription
Fecal Short-chain fatty acids3 monthsThe dry fecal sample was resuspended in 5ml 0.5 % ortho-phosphoric acid in the presence of 250 μl of the pure isobutyric acid as internal standard. Aliquots (60 μl) of the clear supernatant was aspirated and pipetted in a dry clean centrifuge tube containing 240 μl of 0.5% aqueous ortho-phosphoric acid, followed by the addition of 300 μl absolute butanol. Following vigorous shaking, the tubes were centrifuged and the clear supernatant was filtered through a Sartorius membrane filter of 0.25 microns. Aliquots (2 μl) were injected in Gas Chromatograph with a flame ionization detector (FID). The short-chain fatty acid concentrations were expressed in micromoles per gram of dry feces.
16s rRNA3 monthsMetagenomic analysis will be performed. Weighed aliquots (150 mg) of the thawed fecal samples were used for the genomic DNA extraction using the commercial fecal DNA Miniprep Zymo Research kit. The instruction of the manufacturer was followed. The concentration of the harvested DNA in the elute was determined by measuring the optical densities at 230 /260 nm using a nano spectrophotometer. The gnomic DNA is saved at -800C until metagenomic analysis. Standard protocols will be followed with the technical collaboration of Dr Oleg Paily.

Countries

Egypt

Contacts

Primary ContactMosab Gad, PhD
mg.gad@nrc.sci.eg00201009855570
Backup ContactLaila Hussein, PhD
dr.lailahussein@yahoo.com00201006957715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026