Microbial ColonizationNCT06561724
Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children
A study testing Biscuits maltodextrin, Biscuits includes prebiotics tartoufa inulin and Biscuits includes prebiotics chicory inulin in people with Microbial Colonization and Gut Microbiota, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Gut Microbiota
- What is being tested?
- Biscuits maltodextrin, Biscuits includes prebiotics tartoufa inulin and Biscuits includes prebiotics chicory inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- gastrointestinal diseases
- chronic diseases (such as type 1 diabetes)
- intake of antibiotics within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mosab Gad
Dokki, Giza Governorate, 12622
Mosab Gad, PhD, 00201009855570, mg.gad@nrc.sci.eg
laila hussein, PhD, 00201006957715, dr.lailahussein@yahoo.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Microbial Colonization, Gut Microbiota
- Being tested
- Biscuits maltodextrin, Biscuits includes prebiotics tartoufa inulin, Biscuits includes prebiotics chicory inulin
- Keywords
- Gut microbiome, Diarrhea, Irritable bowel syndrome, Inulin prebiotic, Metagenomic analysis, Fecal Secretory immunoglobulin A, Fecal short chain fatty acids
- Medical subject headings
- Communicable Diseases, Diarrhea, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biscuits maltodextrinDietary supplement
Biscuits includes maltodextrin
Biscuits includes prebiotics tartoufa inulinDietary supplement
Biscuits prebiotics
Biscuits includes prebiotics chicory inulinDietary supplement
Biscuits prebiotics
| Study group | Role | What they receive |
|---|---|---|
| Biscuits includes maltodextrin | Active comparator | Maltodextrin is a generally recognized as safe (GRAS) food additive. Functional maltodextrin biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g maltodextrin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. Receives: Dietary Supplement: Biscuits maltodextrin |
| Biscuits includes prebiotics tartoufa inulin | Experimental | Prebiotics is the term for a dietary approach that tries to precisely control the composition and operation of the gut microbiota to promote health. Functional prebiotics biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g tartoufa inulin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. Receives: Dietary Supplement: Biscuits includes prebiotics tartoufa inulin |
| Biscuits includes prebiotics chicory inulin | Experimental | Prebiotics is the term for a dietary approach that tries to precisely control the composition and operation of the gut microbiota to promote health. Functional prebiotics biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g chicory inulin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. Receives: Dietary Supplement: Biscuits includes prebiotics chicory inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal secretory immune globulin A (sIgA)
Fecal 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.
Measured: 2 months
Secondary outcomes (2)
Fecal Short-chain fatty acids
The 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.
Measured: 3 months
16s rRNA
Metagenomic 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jun 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Wright State University
- Responsible party
- Sponsor
- Investigators
- Mosab Gad, PhD, Study chair, National Research Centre, EgyptAmr Elbahnasawy, PhD, Study chair, National Research Centre, EgyptSahar Abdelaziz, PhD, Study chair, National Research Centre, EgyptLaila Hussein, PhD, Principal investigator, National Research Centre, EgyptOleg Paliy, PhD, Principal investigator, Wright State University, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561724
- Sponsor's protocol ID
- 7445052023
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared after publications
Publications
Gad M, Elbahnasawy AS, Ramadan AA, Yamamah GAN, Hussein L. Dietary intervention with edible film-coated multistrain probiotic Lacticaseibacilli in nondairy food matrices significantly increased the recovery of fecal viable Lacticaseibacilli and improved the performance of several colonic biomarkers among slightly malnourished preschool children. Food Funct. 2024 Jan 22;15(2):977-991. doi: 10.1039/d3fo02829a.
PubMed 38179614Mohammad MA, Molloy A, Scott J, Hussein L. Plasma cobalamin and folate and their metabolic markers methylmalonic acid and total homocysteine among Egyptian children before and after nutritional supplementation with the probiotic bacteria Lactobacillus acidophilus in yoghurt matrix. Int J Food Sci Nutr. 2006 Nov-Dec;57(7-8):470-80. doi: 10.1080/09637480600968735.
PubMed 17162326Grimaldi R, Gibson GR, Vulevic J, Giallourou N, Castro-Mejia JL, Hansen LH, Leigh Gibson E, Nielsen DS, Costabile A. A prebiotic intervention study in children with autism spectrum disorders (ASDs). Microbiome. 2018 Aug 2;6(1):133. doi: 10.1186/s40168-018-0523-3.
PubMed 30071894
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06561724
- Acronym / sponsor ID
- 7445052023
- Conditions
- Microbial Colonization, Gut Microbiota
- Keywords
- Gut microbiome, Diarrhea, Irritable bowel syndrome, Inulin prebiotic, Metagenomic analysis, Fecal Secretory immunoglobulin A, Fecal short chain fatty acids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Wright State University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biscuits includes maltodextrin | Active comparator | Dietary Supplement: Biscuits maltodextrinMaltodextrin is a generally recognized as safe (GRAS) food additive. Functional maltodextrin biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g maltodextrin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. |
| Biscuits includes prebiotics tartoufa inulin | Experimental | Dietary Supplement: Biscuits includes prebiotics tartoufa inulinPrebiotics is the term for a dietary approach that tries to precisely control the composition and operation of the gut microbiota to promote health. Functional prebiotics biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g tartoufa inulin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. |
| Biscuits includes prebiotics chicory inulin | Experimental | Dietary Supplement: Biscuits includes prebiotics chicory inulinPrebiotics is the term for a dietary approach that tries to precisely control the composition and operation of the gut microbiota to promote health. Functional prebiotics biscuits were prepared by stacking the biscuits on the table, followed by dispensing of 2g chicory inulin. The biscuits were covered with another piece of biscuit and 1 g of honey was used as binder. The biscuits were packed in bags under vacuum and kept at 40C for the daily supply to the participants. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- gastrointestinal diseases
- chronic diseases (such as type 1 diabetes)
- intake of antibiotics within the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biscuits maltodextrinBiscuits includes maltodextrin | Dietary supplement | Biscuits includes maltodextrin |
| Biscuits includes prebiotics tartoufa inulinBiscuits prebiotics | Dietary supplement | Biscuits includes prebiotics tartoufa inulin |
| Biscuits includes prebiotics chicory inulinBiscuits prebiotics | Dietary supplement | Biscuits includes prebiotics chicory inulin |
Primary outcome
Fecal secretory immune globulin A (sIgA)
Time frame: 2 months
Fecal 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.
2 secondary outcomes
Fecal Short-chain fatty acids
Time frame: 3 months
16s rRNA
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 38179614Gad M, Elbahnasawy AS, Ramadan AA, Yamamah GAN, Hussein L. Dietary intervention with edible film-coated multistrain probiotic Lacticaseibacilli in nondairy food matrices significantly increased the recovery of fecal viable Lacticaseibacilli and improved the performance of several colonic biomarkers among slightly malnourished preschool children. Food Funct. 2024 Jan 22;15(2):977-991. doi: 10.1039/d3fo02829a.
- Background: PubMed 17162326Mohammad MA, Molloy A, Scott J, Hussein L. Plasma cobalamin and folate and their metabolic markers methylmalonic acid and total homocysteine among Egyptian children before and after nutritional supplementation with the probiotic bacteria Lactobacillus acidophilus in yoghurt matrix. Int J Food Sci Nutr. 2006 Nov-Dec;57(7-8):470-80. doi: 10.1080/09637480600968735.
- Background: PubMed 30071894Grimaldi R, Gibson GR, Vulevic J, Giallourou N, Castro-Mejia JL, Hansen LH, Leigh Gibson E, Nielsen DS, Costabile A. A prebiotic intervention study in children with autism spectrum disorders (ASDs). Microbiome. 2018 Aug 2;6(1):133. doi: 10.1186/s40168-018-0523-3.
- Individual participant dataSharing planned: Yes. The data will be shared after publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mosab Gad, PhD study chair
National Research Centre, Egypt
Amr Elbahnasawy, PhD study chair
National Research Centre, Egypt
Sahar Abdelaziz, PhD study chair
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biscuits maltodextrin, Biscuits includes prebiotics tartoufa inulin and Biscuits includes prebiotics chicory inulin in people with Microbial Colonization and Gut Microbiota, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mosab Gad, PhD (00201009855570, mg.gad@nrc.sci.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal secretory immune globulin A (sIgA) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.