Pengaruh Konsumsi Susu Cair Mengandung Serat Inulin terhadap Mikroba di Saluran Cerna dan Kesehatan Anak Usia 3-6 Tahun

1. Background
Registration Number	INA-C3CSPH3
Date of registry approval	12-11-2024
Registration Date	05-11-2024
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	Efek Konsumsi Susu Cair Mengandung Inulin terhadap Komposisi Mikrobiota Usus dan Kesehatan Anak Usia 3-6 Tahun
Public (popular study title)	Pengaruh Konsumsi Susu Cair Mengandung Serat Inulin terhadap Mikroba di Saluran Cerna dan Kesehatan Anak Usia 3-6 Tahun

2. Sponsor and Funding
Primary Sponsor	FUJI NIHON SEITO CORPORATION
Source(s) of monetary or material support	FUJI NIHON SEITO CORPORATION
Other partners

3. Contact details
Principal Investigator
Principal investigator	Dr. dr. Mira Dewi, MSi
City	Bogor
Country	Indonesia
Principal investigator's affiliation	Seafast Center IPB University
Principal Investigator's email address	mirade@apps.ipb.ac.id
Public Queries
Contact person name for public queries	Mira Dewi
Address for public queries	Seafast Center, Jl. Ulin Kampus IPB Dramaga
City	Kabupaten Bogor
Country	Indonesia
ZIP	16680
Affiliation for public queries	Seafast Center IPB University
Email address for public queries	mirade@apps.ipb.ac.id
Phone number for public queries	0251-8629903
Scientific Queries
Name of Contact for scientific queries	Anisah Azizah, S.Gz, M.Gz
Address for scientific queries	Seafast Center, Jl. Ulin Kampus IPB Dramaga
City	Kabupaten Bogor
Country	Indonesia
ZIP	16680
Affiliation of scientific queries contact	Seafast Center IPB University
Email address for scientific queries	mirade@apps.ipb.ac.id

4. IRB & Regulatory
Ethical Approval number	137/KE.03/SK/07/2024
Name of Ethics committee	BADAN RISET DAN INOVASI NASIONAL
Date of Ethic approval	09-07-2024
Contact details of Ethic Committee (phone, email, and office)	Gedung B.J. Habibie Lantai 8 Jalan M.H. Thamrin No. 8, Jakarta10340 Indonesia Website: https://klirensetik.brin.go.id/, Email: klirensetik@brin.go.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Kecamatan Bogor Selatan
Recruitment status	Initial
Date of first enrollment	17-11-2024
Targeted Sample size	00100 -
Number of enrolled participants	100
Date of study completion (last participant, last visit)

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	healthy, non stunting, non diarrhea
Purpose of the study	Basic science
Study type	Interventional
Interventional Study category	Clinical trial
Study phase	Phase 2
Method of allocation	Randomized allocation
Description of the allocation concealment mechanism and sequence generation	Studi Efektivitas Suplementasi Inulin terhadap Mikrobiota Usus Subjek anak laki-laki dan perempuan masing-masing akan dibagi secara acak menggunakan tabel random Microsoft Excel® menjadi 2 kelompok @15 anak yakni kelompok intervensi dan plasebo dengan perbandingan 1:1. Kelompok Intervensi  15 anak laki-laki mendapatkan susu mengandung inulin  15 anak perempuan mendapatkan susu mengandung inulin Kelompok Plasebo (kontrol)  15 anak laki-laki mendapatkan susu mengandung maltodextrin  15 anak perempuan mendapatkan susu mengandung maltodextrin Studi Pengaruh Dosis Suplementasi Inulin terhadap Keluhan Gastrointestinal Subjek anak laki-laki dan perempuan masing-masing akan dibagi secara acak menggunakan tabel random Microsoft Excel® ke dalam 2 kelompok yakni 4 gram dan 6 gram. Jumlah anak laki-laki dan perempuan akan sama untuk setiap kelompok dengan total sebanyak 20 anak per kelompok.
Masking	participants, researcher team
Study intervention (study arm)	Efficacy study  30 children receive milk containing 2gr inulin Dosage study  20 children receive milk containing 4gr inulin  20 children receive milk containing 6gr inulin
Control intervention (control arm)	Efficacy study  30 children receive milk containing 2gr maltodextrin
Intervention assignment	Parallel

7. Eligibility Criteria
Gender inclusion criteria	Not specified
Minimum age	36 month
Maximum age	83 month
Inclusion criteria	Berusia 3–6 tahun, dalam kondisi sehat yang dikonfirmasi melalui anamnesis pemeriksaan fisik oleh dokter anak, Rutin mengonsumsi susu, Tidak mengonsumsi suplemen tambahan, mengisi informed consent
Exclusion criteria	Memiliki intoleransi makanan, alergi makanan, atau kondisi lain yang memerlukan pembatasan diet, mengonsumsi probiotik, prebiotik, atau laksatif secara teratur, mengkonsumsi obat antibiotik secara teratur, status gizi underweight, wasting, stunting, dan obesitas , tidak menyukai susu, mengonsumsi susu berlebihan (susu menggantikan waktu makan >2 kali sehari).

8. Study Outcome
Primary Outcome
Name of primary outcome	Studi efikasi Keragaman Mikrobiota Usus dari sampel feses Studi dosis Keluhan Gastrointestinal (GI)
Metric/method of measurement	Analisis mikrobiota menggunakan metode NGS. Variabel yang dihitung adalah Alpha diversity: Richness, Simpson, and Shannon indexes; Beta diversity:PCoA plot menggunakan jarak Bray–Curtis Gastrointestinal complaints including faeces consistency (Bristol score): reported by mothers, verified by enumerators
Timepoint(s) of measurement	microbiota diversity: baseline (week-0) endline (week-6) gastrointestinal complaints : daily

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	Undecided
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	The protocol is under amendment to the ethical committee due to updated study sites, additional researcher, and product preparation.