Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children

NCT06561724 | Recruiting

• 1 other identifier: 7445052023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (2)

• Fecal Short-chain fatty acids

  3 months

• 16s rRNA

  3 months

Study Arms (3)

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.

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.

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.

Dietary Supplement: Biscuits includes prebiotics chicory inulin

Interventions

Biscuits maltodextrin DIETARY_SUPPLEMENT

Biscuits includes maltodextrin

Biscuits includes maltodextrin

Biscuits includes prebiotics tartoufa inulin DIETARY_SUPPLEMENT

Biscuits prebiotics

Biscuits includes prebiotics tartoufa inulin

Biscuits includes prebiotics chicory inulin DIETARY_SUPPLEMENT

Biscuits prebiotics

Biscuits includes prebiotics chicory inulin

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Wright State University: collaborator

Study Sites (1)

Mosab Gad

Dokki, Giza Governorate, 12622, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 38179614 BACKGROUND

• Mohammad 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.

  PMID: 17162326 BACKGROUND

• Grimaldi 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.

  PMID: 30071894 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases; Diarrhea; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mosab Gad, PhD

  National Research Centre, Egypt

  STUDY CHAIR

• Amr Elbahnasawy, PhD

  National Research Centre, Egypt

  STUDY CHAIR

• Sahar Abdelaziz, PhD

  National Research Centre, Egypt

  STUDY CHAIR

• Laila Hussein, PhD

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

• Oleg Paliy, PhD

  Wright State University, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mosab Gad, PhD

CONTACT

00201009855570; mg.gad@nrc.sci.eg

Laila Hussein, PhD

CONTACT

00201006957715; dr.lailahussein@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: August 20, 2024
• Study Start: June 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be shared after publications
• Access Criteria: Open data access

Locations

EG (1)