- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05215080
The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants (TOFeM)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
All the guardians or parents of the participants in this study will be interviewed in order to record the dietary and sign for inform consent. Parents will be given a journal to record the participant's diet, any sign of colic on subjects, quality of sleep, and wellbeing. All the participants will be fed organic formula milk as a part of their dietary for 12 weeks. Before feeding the formula, the nutritional status will be measured and the participant's fecal will be collected for microbiome and short chain fatty acid (SCFA) examination. Every month the parents will be called in order to assess for child's sickness, allergy, body weight, length, head circumference, and to review their journal.
A visit follow up will be done before and after the study, the tolerance, nutritional status (including body mass index) and fecal collection for all subjects will be performed. The investigators will also collect the allergy related data. Each fecal examination will follow a strict cold chain procedure, each sample will be collected directly, bottled, and frozen to minimize error. The frozen samples will be transported in insulated bags with frozen ice blocks before being transferred to -80°C for storage.
A statistical analysis will be performed using r program and STATA 13.0. The Normality of data distribution will be tested using the Shapiro-Wilk test. To evaluate potential associations between factors in relation to fecal microbiome or SCFAs, Spearman's rank correlations will be calculated. A p-value <0.05 will be considered significant.
The model will be adjusted for potential confounders. Estimated associations will be described as odds ratios (ORs) with 95% confidence intervals (CIs). The non-parametric Wilcoxon test for paired samples will be used to compare different laboratory parameters at different times of collecting samples. The Mann-Whitney U test for unpaired samples will be applied to compare different categorical parameter between infants before and after treatment. Multivariable linear regressions will be done to find out the association of different parameters change before and after treatment.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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South Sulawesi
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Makassar, South Sulawesi, Indonesien, 90245
- Hasanuddin University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy infants 6-7 months of age.
- Gestational age 38-42 weeks
- Birth weight >2700 and <4200 gram
- Not suffering from a major congenital anomaly, severely stunted at birth, not having a thyroid problem, not suffered from prominent gastrointestinal diseases, severe diseases at the time of inclusion (severe pneumonia, severe dehydration, etc)
- Parents want to follow the study by signing the informed consent
Exclusion Criteria:
- Subjects are in the severe disease condition at the time of recruitment
- Severe acute malnutrition
- Have conditions that will influence the nutritional status such as moderate to severe dehydration, organomegaly, edema.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment group
Group of infants aged 6-7 months that given organic formula milk three times a day for three months.
Each serving contains 7 spoons (1 spoon contain 4,6 grams) of milk powder and 210 ml of water.
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Organic formula milk is given to the infants three times a day for three months.
Each serving contains 7 spoons (1 spoon contain 4,6 grams) of milk powder and 210 ml of water.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Participants with diarrhea defined by WHO definition of diarrhea
Tidsramme: 12 weeks
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Evaluate the acceptability of organic formula milk on infants by observing the stool consistency and frequency of passing stool
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12 weeks
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Participants with atopic dermatitis in Hanifin-Rajka criteria
Tidsramme: 12 Weeks
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Evaluate any atopic dermatitis manifestation arise during organic formula milk consumption based on Hanifin Rajka Criteria
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12 Weeks
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Participants with food allergy measured by positive Oral Food Challenge
Tidsramme: 12 Weeks
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Evaluate any allergic reaction during organic formula milk consumption based on positive oral food challenge
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12 Weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diversity of gut microbiota in operational taxonomic unit
Tidsramme: 12 weeks
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Fecal samples obtained and fresh frozen by liquid nitrogen for 16S rRNA analysis Genomic DNA was extracted from fecal samples and purified using Genomic DNA from stool samples (Macherey-Nagel GmbH & Co. KG, Germany).
Each DNA specimen from feces was amplified using the Ion 16S Metagenomics Kit (Thermo Fisher Scientific, Bremen, Germany).
The amplicons were purified and prepared for the sequencing library by using the Ion Plus Fragment Library Kit (Thermo Fisher Scientific) and the Ion Personal Genome Machine (PGM) Hi-Q sequencing kit following the protocol of the kit.
The sequencing runs were performed on the Ion PGM platform (Thermo).
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12 weeks
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Abundance of gut microbiota in operational taxonomic unit
Tidsramme: 12 weeks
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Fecal samples obtained and fresh frozen by liquid nitrogen for 16S rRNA analysis Genomic DNA was extracted from fecal samples and purified using Genomic DNA from stool samples (Macherey-Nagel GmbH & Co. KG, Germany).
Each DNA specimen from feces was amplified using the Ion 16S Metagenomics Kit (Thermo Fisher Scientific, Bremen, Germany).
The amplicons were purified and prepared for the sequencing library by using the Ion Plus Fragment Library Kit (Thermo Fisher Scientific) and the Ion Personal Genome Machine (PGM) Hi-Q sequencing kit following the protocol of the kit.
The sequencing runs were performed on the Ion PGM platform (Thermo).
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12 weeks
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Concentration of gut short chain fatty acids in mMol
Tidsramme: 12 weeks
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Faecal samples obtained.
Reagen used is N-tert-butyldimethylsilyl-N-trifluoroace- tamide (MTBSTFA) (Sigma-Aldrich, St. Louis, MO, USA) and analysis was performed using gas chromatogra- phy-tandem mass spectrometry (GC/MS/MS) platforms on a Shimadzu GCMS-TQ8030 triple quadrupole mass spectrometer (Shimadzu, Kyoto, Japan) with a capillary column (BPX5) (SGE Analytical Science Pty. Ltd., Melbourne, Australia).
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12 weeks
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Body weight in kilograms measured with Krisbow electronic baby scale 10110689
Tidsramme: 12 weeks
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Measurements of weight every 4 weeks
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12 weeks
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Body length in centimeters measured with Krisbow electronic baby scale 10110689
Tidsramme: 12 weeks
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Measurements of length every 4 weeks
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12 weeks
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Head circumference measured with Onemed medline tape measure
Tidsramme: 12 weeks
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Measurements of head circumference every 4 weeks
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12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bahrul Fikri, MD, PhD, Hasanuddin University
Publikationer og nyttige links
Generelle publikationer
- Ohno H. Gut microbial short-chain fatty acids in host defense and immune regulation. Inflammation and regeneration. 2015;35:114-121
- Inoue Y, Shimojo N. Microbiome/microbiota and allergies. Semin Immunopathol. 2015 Jan;37(1):57-64. doi: 10.1007/s00281-014-0453-5. Epub 2014 Oct 18.
- Sakurai K, Miyaso H, Eguchi A, Matsuno Y, Yamamoto M, Todaka E, Fukuoka H, Hata A, Mori C; Chiba study of Mother and Children's Health Group. Chiba study of Mother and Children's Health (C-MACH): cohort study with omics analyses. BMJ Open. 2016 Jan 29;6(1):e010531. doi: 10.1136/bmjopen-2015-010531.
- Simonyte Sjodin K, Vidman L, Ryden P, West CE. Emerging evidence of the role of gut microbiota in the development of allergic diseases. Curr Opin Allergy Clin Immunol. 2016 Aug;16(4):390-5. doi: 10.1097/ACI.0000000000000277.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRP/2021/XI/001/AFA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Organic Formula Milk
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Société des Produits Nestlé (SPN)Medidata Solutions; Veeva Systems; SAS Institute; Cognizant Technology Solutions...RekrutteringAtopisk dermatitis | HudtilstandKina
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Virginia Polytechnic Institute and State UniversityShady Grove Fertility Reproductive Science CenterRekrutteringStress | Infertilitet, kvindeForenede Stater
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Abbott NutritionAfsluttet
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Endourage, LLCAfsluttet
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Baylor College of MedicineProlacta BioscienceAfsluttet
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University of CalgaryUniversity of British Columbia; University of Victoria; NorthernStar Mothers...Ikke rekrutterer endnuMikrobiel koloniseringCanada
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Nutricia UK LtdAfsluttet
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University of ConnecticutAfsluttetTarmmikrobiom | Serum kolesterolForenede Stater
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Abbott NutritionAktiv, ikke rekrutterende
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University of PittsburghNational Institute of Nursing Research (NINR)Afsluttet